Ethicon Endo-Surgery, Inc.
Medical device manufacturer in Guaynabo, PR.
184510(k) clearances
0PMA approvals
101recalls
Device types
- GDW Staple, Implantable 44
- GCJ Laparoscope, General & Plastic Surgery 31
- LFL Instrument, Ultrasonic Surgical 29
- GEI Electrosurgical, Cutting & Coagulation &… 25
- OCW Endoscopic Tissue Approximation Device 11
- KNW Instrument, Biopsy 7
- GAG Stapler, Surgical 5
- FZP Clip, Implantable 4
- GEX Powered Laser Surgical Instrument 4
- OXC Mesh, Surgical, Absorbable, Staple Line… 3
- HET Laparoscope, Gynecologic (And Accessories) 2
- FOZ Catheter, Intravascular, Therapeutic… 2
- NEU Marker, Radiographic, Implantable 2
- KNQ Dilator, Esophageal 2
- KCJ Applicator, Ent 1
- HIF Insufflator, Laparoscopic 1
- FQH Lavage, Jet 1
- KNS Unit, Electrosurgical, Endoscopic (With Or… 1
- GAL Suture, Absorbable, Natural 1
- GCM Endoscope, Rigid 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260196 | ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON…GDW · Traditional | 05/11/2026SE |
| K252906 | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)OXC · Traditional | 01/09/2026SE |
| K252739 | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler…GDW · Traditional | 12/17/2025SE |
| K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler…GDW · Traditional | 05/14/2025SE |
| K243276 | ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler…GDW · Traditional | 02/25/2025SE |
| K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler…GDW · Traditional | 10/28/2024SE |
| K241629 | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S)…GAG · Special | 07/03/2024SE |
| K232313 | LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic…FZP · Special | 08/29/2023SE |
| K230387 | ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue…GEI · Traditional | 04/13/2023SE |
| K223760 | ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR…GDW · Traditional | 03/15/2023SE |
| K221790 | HARMONIC 700 ShearsLFL · Traditional | 02/28/2023SE |
| K221343 | ECHELON ENDOPATH Staple Line ReinforcementOXC · Traditional | 09/16/2022SE |
| K213633 | ECHELON 3000 45mm Stapler, ECHELON 3000 60mm StaplerGAG · Traditional | 04/08/2022SE |
| K211273 | Harmonic Hand Piece, Blue, Harmonic Hand Piece, GrayLFL · Special | 05/21/2021SE |
| K201696 | ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer…GEI · Traditional | 01/22/2021SE |
| K201066 | ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved…GEI · Traditional | 01/22/2021SE |
| K202665 | Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm…GDW · Special | 10/15/2020SE |
| K201280 | Ethicon Circular Stapler, Ethicon Circular Stapler -XL SealedGDW · Special | 07/27/2020SE |
| K200420 | Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green…GDW · Traditional | 06/29/2020SE |
| K200253 | Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke…GEI · Traditional | 05/27/2020SE |
| K200841 | Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11GEI · Traditional | 05/11/2020SE |
| K191555 | HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm lengthLFL · Traditional | 02/28/2020SE |
| K190937 | Echelon Endopath Staple Line ReinforcementOXC · Traditional | 10/14/2019SE |
| K183435 | Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and BlackGDW · Traditional | 02/06/2019SE |
| K181488 | LIGACLIP 12mm L Endoscopic Rotating Multiple Clip ApplierFZP · Traditional | 10/30/2018SE |
| K181653 | Ethicon Circular Stapler, Ethicon Circular Stapler -XL SealedGDW · Traditional | 09/18/2018SE |
| K180403 | ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue…GEI · Traditional | 05/23/2018SE |
| K180031 | Endopath Electrosurgery Probe Plus IIGEI · Traditional | 05/07/2018SE |
| K172580 | ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer…GEI · Traditional | 11/20/2017SE |
| K163523 | ECHELON CIRCULAR Powered StaplerGDW · Traditional | 04/18/2017SE |
| K163548 | ENSEAL X1 Large Jaw Tissue SealerGEI · Traditional | 02/14/2017SE |
| K163454 | ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH…GDW · Special | 01/05/2017SE |
| K160554 | Enseal X1 Large Jaw Tissue SealerGEI · Traditional | 09/09/2016SE |
| K160128 | Endopath Electrosurgery Probe Plus IIGEI · Traditional | 04/28/2016SE |
| K160521 | ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mmGDW · Special | 03/22/2016SE |
| K151136 | Harmonic HookLFL · Traditional | 03/04/2016SE |
| K150840 | Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip ApplierFZP · Traditional | 09/10/2015SE |
| K151340 | HARMONIC Focus Long Shears + Adaptive Tissue TechnologyLFL · Special | 07/10/2015SE |
| K150026 | Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife…GDW · Traditional | 05/18/2015SE |
| K141952 | Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon…GDW · Traditional | 11/24/2014SE |
| K141122 | Harmonic Scallop Blade, Generator G11GEI · Traditional | 09/15/2014SE |
| K140560 | Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM, Standard, Echelon…GDW · Traditional | 04/22/2014SE |
| K132522 | Harmonic Ace Curved Shears with Ergonomic HandleLFL · Traditional | 12/16/2013SE |
| K133314 | Harmonic Focus Shears + Adaptive Tissue TechnologyLFL · Traditional | 12/03/2013SE |
| K132512 | Harmonic Ace Curved Shears with Scissor Handle, Harmonic Ace Curved Shears with…LFL · Special | 10/24/2013SE |
| K131663 | Echelon Endoscopic Linear Cutter Reload, BlackGDW · Traditional | 10/18/2013SE |
| K132612 | Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace + Laparoscopic…LFL · Traditional | 10/17/2013SE |
| K131435 | Enseal G2 Tissue Sealer, Straight Jaw, Enseal G2 Tissue Sealer, Curved Jaw, Enseal Trio…GEI · Traditional | 10/03/2013SE |
| K130653 | Echelon Flex 45 Powered Articulating Endoscopic Linear Cutter; Echelon Flex 60 Powered…GDW · Special | 03/29/2013SE |
| K123212 | Ethicon Endo-Surgery Enseal G2 Cordless Tissue SealersPDG · Traditional | 03/08/2013SE |
| K122797 | Enseal G2 Articulating Tissue Sealers, Straight Jaw, Enseal G2 Articulating Tissue…GEI · Traditional | 01/25/2013SE |
| K123141 | Enseal Trio Tissue Sealing DeviceGEI · Special | 10/25/2012SE |
| K122511 | Endopath Xcel Bladeless Trocar with Optiview Technology Endopath Xcel Blunt Tip Trocar…GCJ · Traditional | 10/01/2012SE |
| K121550 | Harmonic Ace Laparoscopic 5MM Diameter Shears 36CM Length + Adaptive Tissue TechnologyLFL · Traditional | 08/22/2012SE |
| K121600 | Echelon 60 Endoscpic Linear Cutter Reload, WhiteGDW · Traditional | 07/16/2012SE |
| K120729 | Haronis Ace Laparoscopic 5MM Diameter Shears 36CM Length +Adaptive Tissue Technology…LFL · Traditional | 05/17/2012SE |
| K112056 | Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45 Endoscopic…GDW · Traditional | 12/19/2011SE |
| K111195 | Valutrus Reusable Circular Stapler and Disposable ReloadsGDW · Traditional | 08/03/2011SE |
| K111111 | Endopath Ets 35MM Endoscopic Linear Cutter and Reloads, and Ets-Flex 35MM Endoscopic…GDW · Traditional | 06/08/2011SE |
| K103672 | Reusable PPH Circular Stapler Handle, PPH Circular Stapler Reload & Accessory SetGDW · Traditional | 04/08/2011SE |
| K110385 | Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear CutterGDW · Traditional | 03/25/2011SE |
| K110049 | Reusable Linear Stapler HandleGDW · Traditional | 02/10/2011SE |
| K101520 | Enseal Tissue Sealing Devices Model: NSEAL514H-535H, NSEAL514RH-535RHGEI · Traditional | 12/10/2010SE |
| K102632 | Ethicon Endo-Surgery 5MM Laparoscopic Multi-Feed StaplerGDW · Traditional | 10/07/2010SE |
| K093899 | Mammotome Biopsy System for Molecular ImagingKNW · Traditional | 04/29/2010SE |
| K100597 | Harmonic Focus ShearsLFL · Traditional | 04/07/2010SE |
| K093896 | Ethicon Endo Surgery Slotted AnoscopeFER · Traditional | 03/25/2010SE |
| K091259 | Ethicon Endo-Surgery Flexible Bipolar Hemostasis ForcepsGEI · Traditional | 01/15/2010SE |
| K091824 | Ethicon Endo-Surgery Rotating Endoscopic Scissors, Model IN2507GEI · Traditional | 11/27/2009SE |
| K093236 | Ethicon Endo-Surgeryoptical DilatorKNQ · Special | 11/10/2009SE |
| K091290 | Ethicon Endo-Surgery Rotating Hook Knife, Model IN2508GEI · Traditional | 10/29/2009SE |
| K092577 | Ethicon Endo-Surgery Linear Cutter 55MM (NTLC55),SELECTABLE Cartridge 55 / 75MM…GDW · Traditional | 09/15/2009SE |
| K091322 | Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G, CR40B, CR40GGDW · Traditional | 06/01/2009SE |
| K082955 | Ethicon Endo-Surgery Articulating Hook Knife, Model IN4505GEI · Traditional | 01/15/2009SE |
| K081146 | Echelon Endoscopic Linear Cutters (Articulating and Straight)GDW · Traditional | 06/26/2008SE |
| K073288 | Ethicon Endo Surgery Articulating SnareFDI · Traditional | 06/12/2008SE |
| K080839 | Echelon Gray Cartridge, Model ERC45MGDW · Traditional | 05/21/2008SE |
| K073484 | Ethicon Endo Surgery Sheath and Articulating Accessory Channel - Gastroscope, Model…ODC · Traditional | 03/10/2008SE |
| K073046 | Ethicon Endo Surgery Articulating Needle Knife, Model 2504GEI · Traditional | 02/25/2008SE |
| K072203 | Harmonic 10CM Combination Hook BladeLFL · Traditional | 09/25/2007SE |
| K070151 | Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and Knotting Element ApplierOCW · Traditional | 08/15/2007SE |
| K070198 | Endopath Dextrus Seal Cap Assembly with Accessories and Endopath Dextrus Fixed-Length…GCJ · Traditional | 06/13/2007SE |
| K070887 | Endopath Linear Cutters and Staplers and ECHELON60 Endoscopic Linear Cutters and…GDW · Traditional | 05/25/2007SE |
| K062869 | Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G, CR40B and CR40GGDW · Traditional | 02/26/2007SE |
| K063192 | Harmonic Focus Curved Shears and Torque Wrench, Harmonic Blue Hand Piece and Test TipLFL · Traditional | 01/30/2007SE |
| K062209 | Basx Bladeless TrocarGCJ · Traditional | 10/10/2006SE |
| K062000 | Harmonic Wave Coagulating Shears with Scissor Handel and Hand Control, Model WAVE18S…LFL · Traditional | 09/25/2006SE |
| K061770 | Ethicon Endo Surgery Endoscopic Suturing SystemOCW · Traditional | 09/25/2006SE |
| K061156 | Endopath Endocutter 60 Endoscopic Linear Cutter, Models EC60, SC60 and LONG60 and…GDW · Traditional | 07/03/2006SE |
| K061192 | Blue Colour Powder Free Barrierpro Polymer BP2000 Polybutadiene Copolymer Examination…LZA · Traditional | 05/23/2006SE |
| K060245 | Harmonic Scalpel Blades and ShearsLFL · Traditional | 04/07/2006SE |
| K053631 | Contour Transtar Curved Cutter Stapler SetGDW · Traditional | 01/30/2006SE |
| K053056 | Harmonic Scalpel Blades and ShearsLFL · Traditional | 01/19/2006SE |
| K051950 | Inscope Multi-Clip Applier, Models IN22321, IN23321MND · Traditional | 10/07/2005SE |
| K051301 | Proximate PPH Hemorrhoidal Circular Stapler and AccessoriesGDW · Traditional | 08/30/2005SE |
| K051036 | Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P, ACE36PLFL · Traditional | 06/02/2005SE |
| K051002 | Endopath Endocutter 60 Endoscopic Linear CutterGDW · Traditional | 05/17/2005SE |
| K050344 | Ligaclip 5 M/L MM Endoscopic Multiple Clip ApplierFZP · Traditional | 03/14/2005SE |
| K042777 | Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36PLFL · Traditional | 12/01/2004SE |
| K042897 | Autobahn Tissue Closure Device and Disposable CartridgeGAL · Traditional | 11/19/2004SE |
| K042753 | Mammotome MR Biopsy SystemKNW · Traditional | 11/08/2004SE |
| K033700 | Mammotome Ex Hand Held SystemKNW · Traditional | 02/20/2004SE |
| K040038 | Curved Cutter Stapler, Models CS40B, CS40G; Reload for Curved Stapler, Models CR40B, CR40GGDW · Traditional | 02/04/2004SE |
| K031147 | Optical DVS (Dual Vector Shearing) Esophageal DilatorKNQ · Traditional | 01/12/2004SE |
| K033269 | Endopath Endocutter Gray Cartridge, Model 6R45M/GRAY Cartridge ReloadOCW · Traditional | 12/10/2003SE |
| K032676 | Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip TrocarGCJ · Traditional | 10/30/2003SE |
| K030472 | Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held SystemKNW · Traditional | 10/09/2003SE |
| K030925 | Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model PPH01GDW · Traditional | 05/15/2003SE |
| K030571 | Acuvance Plus Safety IV Catheter, Protectiv Plus Safety IV Catheter, Optiva IV CatheterFOZ · Traditional | 03/28/2003SE |
| K030411 | Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Model PPH03GDW · Traditional | 03/20/2003SE |
| K023182 | Indigo Optima Laser System, Optima Diffuser-Tip Fiberoptic-Bph, Optima Bare-Tip…GEX · Special | 10/24/2002SE |
| K021266 | Endo Window High Frequency Electrocautery Device, Model EW018KNS · Traditional | 09/27/2002SE |
| K020779 | Proximate and Endopath Linear Cutters and StaplersGDW · Traditional | 06/05/2002SE |
| K020276 | 8 Gauge Micromark II Tissue Marker, Models C1540 & C1535NEU · Traditional | 04/12/2002SE |
| K020428 | Endopath Dilating Tip Trocar, Model #512XDGCJ · Special | 03/04/2002SE |
| K013749 | Endoanchor and OpenanchorGDW · Traditional | 02/11/2002SE |
| K013576 | Pericscope, Model # PERISC1GCJ · Traditional | 01/25/2002SE |
| K013493 | Indigo Optima Laser SystemGEX · Traditional | 12/13/2001SE |
| K013413 | Micromark II Tissue Marker,Model C1535NEU · Traditional | 12/03/2001SE |
| K012176 | Ultracision Harmonic Scalpel Blades with Protective Sleeve, Models DH105, DH145, SH105…LFL · Traditional | 10/01/2001SE |
| K011538 | Endopath Non-Bladed Solid Obturator Trocar SystemGCJ · Traditional | 08/09/2001SE |
| K012128 | Protectiv Acuvance IV Catheter SystemFOZ · Traditional | 08/01/2001SE |
| K011501 | Endopouch RetrieverGCJ · Traditional | 07/19/2001SE |
| K011257 | Endopath Non-Bladed Obturator Trocar System (5 MM)GCJ · Traditional | 07/13/2001SE |
| K010870 | Lap Disc 120 X 120, Model LD111, Lap Disc 120 X 100, Model LD112, Lap Disc 70 X 70…GCJ · Traditional | 06/18/2001SE |
| K010898 | Ultracision Harmonic Scalpel Blades, Model DH105,DH145,SH105, SH145,HC145LFL · Traditional | 05/31/2001SE |
| K002981 | Ultracision Harmonic Scalpel Coagulating Shears, Model LCSC5,LCSC1,CS23C,CS231,CS14C,CS14…GEI · Traditional | 04/09/2001SE |
| K003953 | Indigo Diffuser-Tip Fiberoptic with Temperature Sensing Option, Model LF001GEX · Traditional | 03/16/2001SE |
| K003952 | Indigo Laseroptic Treatment SystemGEX · Traditional | 03/16/2001SE |
| K003297 | Mammotome Hand Held Probe, Model MHH8KNW · Traditional | 01/18/2001SE |
| K002906 | Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07LFL · Traditional | 12/15/2000SE |
| K002398 | Endopath ETS45, Ets FLEX45, Ets COMPACT-FLEX45 Linear Cutters, Ets FLEX45 and Ets…OCW · Traditional | 11/03/2000SE |
| K001220 | Endopath Sureseal Reducer CapHET · Traditional | 05/16/2000SE |
| K994280 | Ultracision Harmonic Scalpel Sharp Curved Blade/Fast Blade, Model HF105LFL · Traditional | 03/17/2000SE |
| K993054 | Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5, LCS-C1, CS-23C, CS-231…LFL · Traditional | 12/09/1999SE |
| K992813 | 11 Gauge Probe, Stereotactic, 14 Gauge Probe, STEREOTACTIC,14 Gauge Probe, Ultrasound…KNW · Traditional | 11/18/1999SE |
| K992612 | Endopath Endoscopic Tissue Fastening System with Coated Vicryl, Models SW210, SW220…GCJ · Traditional | 10/14/1999SE |
| K990362 | Instrument, Ultrasonic, ScalpelGEI · Traditional | 09/17/1999SE |
| K991980 | Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster and…KNW · Traditional | 08/17/1999SE |
| K984240 | Endopath Endoscopic InstrumentsGEI · Abbreviated | 06/22/1999SE |
| K991030 | Proximate HCS Hemorrhoidal Circular Stapler and AccessoriesGDW · Traditional | 05/17/1999SE |
| K990028 | Endopath Optiview Optical Surgical Obturator and SleeveGCJ · Traditional | 04/01/1999SE |
| K990430 | Ultracision Harmonic Scalpel Hand PieceLFL · Special | 03/12/1999SE |
| K983925 | Endopath Ultra Veress NeedleHIF · Traditional | 02/03/1999SE |
| K983536 | Proximate Curved and Straight Intraluminal StaplersGDW · Traditional | 12/18/1998SE |
| K983316 | Ultracision 5MM InstrumentsLFL · Special | 10/21/1998SE |
| K980815 | Endopath EZ45 Endoscopic Linear CutterOCW · Traditional | 05/01/1998SE |
| K980099 | Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5))LFL · Traditional | 04/09/1998SE |
| K980023 | Endopath and Proximate Linear CuttersGCJ · Traditional | 03/18/1998SE |
| K980022 | Endopath Endoscopic Tissue Fastening System (Etfs)GCJ · Traditional | 03/09/1998SE |
| K973803 | Flexview CO2 Blower with MistFQH · Traditional | 12/16/1997SE |
| K973139 | Endopath Ultra-Retractor/ Endopath Vessel DissectorGCJ · Traditional | 11/13/1997SE |
| K972578 | Endopath Optiview Optical Surgical Obturator and SleeveGCJ · Traditional | 10/01/1997SE |
| K972679 | Endopath Endoscopic Tissue Fastening System (Etfs)GCJ · Traditional | 09/19/1997SE |
| K971475 | Shielded Surgical TrocarGCJ · Traditional | 08/21/1997SE |
| K971738 | Endopath Resposable Trocar SystemGCJ · Traditional | 08/07/1997SE |
| K971302 | Ultracision 5MM Laparosonic Hook Blades, Ultracision HS2 BladeLFL · Traditional | 07/07/1997SE |
| K970720 | Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 No Knife Endoscopic Linear…OCW · Traditional | 06/27/1997SE |
| K965045 | Tristar LP Torcar with Low Profile Threaded SleeveHET · Traditional | 05/05/1997SE |
| K970079 | Proximate Disposable Skin StaplerGAG · Traditional | 03/11/1997SE |
| K963760 | Non-Shielded Surgical Trocar and SleeveGCJ · Traditional | 01/08/1997SE |
| K962584 | Ultracision 5MM Hard Sheath Laparosonic BladeLFL · Traditional | 11/04/1996SE |
| K962258 | Endopath Endoscopic Articulating Stapler with Sweiveling Cartridge TipGAG · Traditional | 09/11/1996SE |
| K961264 | Endopath Ez-Rf Linear Cutter and CoagulationGEI · Traditional | 07/19/1996SE |
| K961390 | Endopath Ets Linear/Ets-Flex Articulating Linear Endoscopic CutterOCW · Traditional | 06/25/1996SE |
| K955120 | Hand-Held Retractor, Dissector & DissectorGCM · Traditional | 01/26/1996SE |
| K954089 | Endopath Open or Endoscopic Electrosugical Coagulation & Cutting DeviceGCJ · Traditional | 11/02/1995SE |
| K952842 | Endopath* Tristar Flat Bladed Surgical Obturator & SleeveGCJ · Traditional | 07/31/1995SE |
| K951546 | Endopath and Proximate Linear Cutters and StaplersGCJ · Traditional | 06/21/1995SE |
| K951444 | Endopath Optical Access NeedkleGCJ · Traditional | 04/25/1995SE |
| K946241 | Endopath(R) Tristar(Tm) Dissector and Tissue ManipulatorGCJ · Traditional | 01/27/1995SE |
| K945202 | Endopath Endoscopic Reloadable Linear Cutter with Safety Loc-Out and Reloading UnitOCW · Traditional | 01/19/1995SE |
| K941027 | Endopath Optical Obturator and SleeveGCJ · Traditional | 08/23/1994SE |
| K942450 | EndopathGBZ · Traditional | 08/05/1994SE |
| K940967 | Modified Endopath IlsOCW · Traditional | 05/27/1994SE |
| K935756 | Endoscopic Articulating Multi-Feed Stapler with Reload UnitOCW · Traditional | 04/21/1994SE |
| K932434 | Proximate Articulating Linear StaplerOCW · Traditional | 02/07/1994SE |
| K932476 | Proximate Reloadable Articulating Linear StaplerGAG · Traditional | 12/01/1993SE |
| K933160 | Procedure KitsGCJ · Traditional | 10/01/1993SE |
| K924916 | Endopath Endoscopic Tissue RetractorGCJ · Traditional | 06/25/1993SE |
| K932282 | Endopath II Disposable Surgical Trocar & SleeveGCJ · Traditional | 06/22/1993SE |
| K931111 | Endopath Disposable Flexible Surgical CannulaGCJ · Traditional | 06/22/1993SE |
| K924035 | Endopath II Disposable Surgical Trocar & SleeveGCJ · Traditional | 04/07/1993SE |
| K923679 | Endopath Tissue Retaining ComponentKCJ · Traditional | 09/09/1992SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0147-2026 Class II | ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or…The devices were shipped unsterilized. | 09/11/2025Open, Classified |
| Z-1746-2025 Class I | Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product…Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures… | 04/22/2025Open, Classified |
| Z-1516-2025 Class II | ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MHIdentified curing issues with the silicone during the needles manufacturing process. | 03/07/2025Open, Classified |
| Z-1515-2025 Class II | PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRMIdentified curing issues with the silicone during the needles manufacturing process. | 03/07/2025Open, Classified |
| Z-1514-2025 Class II | PDSIIVIO30IN(75CM)USP6-0(M0.7)D/AC-1Identified curing issues with the silicone during the needles manufacturing process. | 03/07/2025Open, Classified |
| Z-1513-2025 Class II | PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MPIdentified curing issues with the silicone during the needles manufacturing process. | 03/07/2025Open, Classified |
| Z-0834-2024 Class II | ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath…There is the potential for incomplete staple line formation during the firing sequence, without most or all… | 12/11/2023Open, Classified |
| Z-2356-2021 Class II | HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when…An internal component may be cracked and become lodged behind the energy button potentially resulting in… | 07/20/2021Open, Classified |
| Z-2355-2021 Class II | HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when…An internal component may be cracked and become lodged behind the energy button potentially resulting in… | 07/20/2021Open, Classified |
| Z-2326-2021 Class II | ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation…Mislabeled: Labeled on the package as 60mm contains 45mm devices | 06/03/2021Terminated |
| Z-0656-2020 Class II | Ligamax 5 mm Endoscopic Multiple Clip ApplierA potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek… | 11/07/2019Terminated |
| Z-0203-2020 Class I | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60AThe staplers may contain an out of specification anvil component within the jaw of the device. This… | 10/03/2019Terminated |
| Z-0202-2020 Class I | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60AThe staplers may contain an out of specification anvil component within the jaw of the device. This… | 10/03/2019Terminated |
| Z-0201-2020 Class I | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60AThe staplers may contain an out of specification anvil component within the jaw of the device. This… | 10/03/2019Terminated |
| Z-0200-2020 Class I | ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60AThe staplers may contain an out of specification anvil component within the jaw of the device. This… | 10/03/2019Terminated |
| Z-1890-2019 Class II | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145CObserved reported incidence rate for harm associated with intraoperative bleeding | 05/15/2019Terminated |
| Z-1889-2019 Class II | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137CObserved reported incidence rate for harm associated with intraoperative bleeding | 05/15/2019Terminated |
| Z-1888-2019 Class II | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125CObserved reported incidence rate for harm associated with intraoperative bleeding | 05/15/2019Terminated |
| Z-1278-2019 Class I | Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery…The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 04/11/2019Completed |
| Z-1277-2019 Class I | Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon Endo-Surgery…The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 04/11/2019Completed |
| Z-1276-2019 Class I | Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery…The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 04/11/2019Completed |
| Z-1275-2019 Class I | Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery…The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 04/11/2019Completed |
| Z-1274-2019 Class I | Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The Ethicon…The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 04/11/2019Completed |
| Z-1273-2019 Class I | Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The Ethicon…The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 04/11/2019Completed |
| Z-1272-2019 Class I | Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon…The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 04/11/2019Completed |
| Z-1271-2019 Class I | Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The Ethicon…The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 04/11/2019Completed |
| Z-1270-2019 Class I | Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon Endo-Surgery…The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 04/11/2019Completed |
| Z-1269-2019 Class I | Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon Endo-Surgery…The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 04/11/2019Completed |
| Z-1268-2019 Class I | Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon Endo-Surgery…The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 04/11/2019Completed |
| Z-1267-2019 Class I | Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery…The staplers may have an insufficient firing stroke to break the washer and completely form staples. | 04/11/2019Completed |
| Z-0696-2019 Class II | PROXIMATE PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE PPH…Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding… | 12/07/2018Terminated |
| Z-0695-2019 Class II | PROXIMATE HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE HCS…Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding… | 12/07/2018Terminated |
| Z-2049-2018 Class II | HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved…The devices may have been assembled with an internal component that may cause continuous or inadvertent… | 05/03/2018Terminated |
| Z-2048-2018 Class II | HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved…The devices may have been assembled with an internal component that may cause continuous or inadvertent… | 05/03/2018Terminated |
| Z-1889-2018 Class II | 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm…Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition… | 03/26/2018Terminated |
| Z-1888-2018 Class II | 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm…Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition… | 03/26/2018Terminated |
| Z-1887-2018 Class II | 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm…Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition… | 03/26/2018Terminated |
| Z-1886-2018 Class II | 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm…Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition… | 03/26/2018Terminated |
| Z-1885-2018 Class II | 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm…Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition… | 03/26/2018Terminated |
| Z-0672-2018 Class II | Disposable Curved Circular Staplers Product Usage: Staplers have application throughout…There is a potential for the devices to create staples that do not meet formed staple height specifications… | 10/23/2017Terminated |
| Z-2174-2017 Class II | Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MMThere is a risk that the pinion gear in the device could fail under extreme use cases. | 03/31/2017Terminated |
| Z-0296-2017 Class II | Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOPATH ETS-Flex…Quality control identified a component issue where the pinion gear in the device could fail under extreme… | 07/15/2016Terminated |
| Z-0295-2017 Class II | Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH ETS-Flex…Quality control identified a component issue where the pinion gear in the device could fail under extreme… | 07/15/2016Terminated |
| Z-0278-2016 Class II | HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length)…Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging. | 09/23/2015Terminated |
| Z-2374-2015 Class I | SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated…Ethicon has found that disinfecting methods not specified in the Instructions For Use (IFU) have led to the… | 05/13/2015Terminated |
| Z-1641-2015 Class II | ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The…During an internal inspection of the production process the firm discovered an issue which may cause the… | 02/26/2015Terminated |
| Z-2610-2014 Class II | PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE…The device may have a non-conforming component that may cause the device to fire an unformed staple. | 08/12/2014Terminated |
| Z-0151-2014 Class II | Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters…During aging studies, the firm determined that the gastric belts were unable to pass the test requirements… | 09/30/2013Terminated |
| Z-0150-2014 Class II | Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters…During aging studies, the firm determined that the gastric belts were unable to pass the test requirements… | 09/30/2013Terminated |
| Z-0149-2014 Class II | Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters…During aging studies, the firm determined that the gastric belts were unable to pass the test requirements… | 09/30/2013Terminated |
| Z-1530-2013 Class II | ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek…Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due… | 05/13/2013Terminated |
| Z-1777-2013 Class II | LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile…Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple… | 04/12/2013Terminated |
| Z-1776-2013 Class II | LIGACLIP Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays), 10mm…Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple… | 04/12/2013Terminated |
| Z-1775-2013 Class II | LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The…Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple… | 04/12/2013Terminated |
| Z-1772-2013 Class II | Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks…The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek… | 04/08/2013Terminated |
| Z-0758-2013 Class II | Ethicon Endo-Surgery Inc. The ENSEAL G2 Tissue Sealers are indicated for bipolar…Potential for self activation while the device is in use, which may result in unintended thermal damage. | 11/06/2012Terminated |
| Z-0918-2013 Class II | PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure…Damage to the packaging may have compromised the sterility of the device. | 10/04/2012Terminated |
| Z-0057-2013 Class I | Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE HCS…Ethicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXIMATE PPH… | 08/03/2012Terminated |
| Z-1673-2012 | HPBLUE: HARMONIC Blue Hand Piece; HP054: HARMONIC Hand Piece; Non-Sterile products are…Ethicon Endo-Surgery initiated a voluntary recall due to some lot numbers of the HARMONIC Hand Piece (HP054)… | 03/16/2012Terminated |
| Z-1627-2012 | The ECHELON 60 Endoscopic Linear Cutter - Straight, compact ECHELON 60 Endoscopic Linear…There is a possibility of a component breakage, which may cause the device to stay locked on tissue after… | 03/02/2012Terminated |
| Z-1247-2012 | ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Straight Jaw, Model #…Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL G2 Curved… | 01/26/2012Terminated |
| Z-1246-2012 | ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Straight Jaw, Model # NSLG2S14 and…Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL G2 Curved… | 01/26/2012Terminated |
| Z-1245-2012 | ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Curved Jaw, Model #…Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL G2 Curved… | 01/26/2012Terminated |
| Z-1244-2012 | ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Curved Jaw, Model # NSLG2C14 and…Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL G2 Curved… | 01/26/2012Terminated |
| Z-3187-2011 | ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters, Model Number(s): SCW45…Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENDOPATH ETS… | 07/29/2011Terminated |
| Z-0336-2011 | ENDOPATH XCEL" with OPTIVIEW" Technology trocar Product Codes: Product Code #:…This recall has been initiated because Ethicon Endo-Surgery is aware of an increase in reports of leaking in… | 09/27/2010Terminated |
| Z-0304-2011 | Velocity" Injection Port and Applier Product Code PT2XV, Lot #: 1110603, 10060505…The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate… | 09/27/2010Terminated |
| Z-0303-2011 | SAGB VC Swedish Adjustable Gastric Band including Velocity" Injection Port Applier…The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate… | 09/27/2010Terminated |
| Z-0302-2011 | SAGB QuickClose Swedish Adjustable Gastric Band including Velocity" Injection Port and…The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate… | 09/27/2010Terminated |
| Z-0301-2011 | REALIZE Injection Port and Applier. Product Code RLZPT2, Lot #: ZHLBCG, ZHPBB8, ZJBBBD…The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate… | 09/27/2010Terminated |
| Z-0300-2011 | REALIZE Adjustable Gastric Band-C with Endoscopic Dissector. Product Code RLZB32D1, Lot…The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate… | 09/27/2010Terminated |
| Z-0299-2011 | REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector, Calibration Tube and…The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate… | 09/27/2010Terminated |
| Z-0298-2011 | REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector and calibration tube.…The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate… | 09/27/2010Terminated |
| Z-0297-2011 | REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector and 15mm XCEL" trocar…The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate… | 09/27/2010Terminated |
| Z-0296-2011 | REALIZE Adjustable Gastric Band-C Pak with 15mm XCEL" trocar Product Code RLZB32T, Lot…The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate… | 09/27/2010Terminated |
| Z-0295-2011 | REALIZE Adjustable Gastric Band-C Product Code RLZB32, Lot #: ZJMBP7, ZJMBP8, ZJMBP9…The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate… | 09/27/2010Terminated |
| Z-0294-2011 | REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector, Calibration Tube and 15mm…The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate… | 09/27/2010Terminated |
| Z-0293-2011 | REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector and Calibration Tube…The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate… | 09/27/2010Terminated |
| Z-0292-2011 | REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector and 15mm XCEL" trocar…The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate… | 09/27/2010Terminated |
| Z-0291-2011 | REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector Product Code RLZB22D1, Lot…The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate… | 09/27/2010Terminated |
| Z-0290-2011 | REALIZE Adjustable Gastric Band Pak with 15mm XCEL" trocar Product Code RLZB22T, Lot #:…The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate… | 09/27/2010Terminated |
| Z-0289-2011 | REALIZE Adjustable Gastric Band, Injection Port and Applier Product Code: RLZB22…The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate… | 09/27/2010Terminated |
| Z-2635-2010 | Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05The weld that connects the electrode to the active rod was separated. This connection is critical to the… | 07/09/2010Terminated |
| Z-1069-2011 | FlexTray Procedure Delivery System, Product Codes: KBW71SXL- Bariatric Surgery Trays…The firm initiated this second subsequent recall because the affected devices can remain closed and clamped… | 03/27/2009Terminated |
| Z-1068-2011 | ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Product Codes: ATS45…The firm initiated this second subsequent recall because the affected devices can remain closed and clamped… | 03/27/2009Terminated |
| Z-0361-2011 | ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Model # ATS45. Manfuactured…The mechanism that connects the articulation joint to the device shaft may cause the jaws of the cutters to… | 01/13/2009Terminated |
| Z-0663-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Needle Probe (Product…Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of… | 12/09/2008Terminated |
| Z-0662-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Curved Dissector Probe…Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of… | 12/09/2008Terminated |
| Z-0661-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Right Angle Probe…Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of… | 12/09/2008Terminated |
| Z-0660-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Spatula Probe (Product…Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of… | 12/09/2008Terminated |
| Z-0659-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Hook Probe (Product…Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of… | 12/09/2008Terminated |
| Z-0658-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Curved Dissector Probe…Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of… | 12/09/2008Terminated |
| Z-0657-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Right Angle Probe…Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of… | 12/09/2008Terminated |
| Z-0656-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Spatula Probe (Product…Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of… | 12/09/2008Terminated |
| Z-0655-2009 | Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Hook Probe (Product…Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of… | 12/09/2008Terminated |
| Z-2164-2008 | FlexTray"Procedure Delivery System ENDOPATH; FBW67XL, FD064, FDB15, TGL45XL, XBB02B…The firm discovered a component production issue which may cause the cartridge to deploy an incomplete… | 04/24/2008Terminated |
| Z-2163-2008 | ENDOPATHETS and ETS-Flex Endoscopic Linear Cutter Reload; TR35W. Utilized during…The firm discovered a component production issue which may cause the cartridge to deploy an incomplete… | 04/24/2008Terminated |
| Z-2162-2008 | ENDOPATHETS Endoscopic Linear Cutter, TSW35. Utilized during general, gynecologic…The firm discovered a component production issue which may cause the cartridge to deploy an incomplete… | 04/24/2008Terminated |
| Z-2161-2008 | ENDOPATHETS-Flex Endoscopic Linear Cutter, ATW35 Utilized during general, gynecologic…The firm discovered a component production issue which may cause the cartridge to deploy an incomplete… | 04/24/2008Terminated |
| Z-0565-2008 | Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD…Sterility (package integrity) compromised; Damaged packaging may have compromised the sterility of the… | 11/06/2007Terminated |
| Z-0980-2007 | Proximate PPH, Procedure for Prolapse and Hemmorroids Set, REF PPH03. Each set contains:…The adhesive used to bond the casing of the device may have migrated to the staple driver. While the device… | 04/02/2007Terminated |