Aesculap, Inc.
Medical device manufacturer in Center Valley, PA.
218510(k) clearances
0PMA approvals
46recalls
Device types
- GEI Electrosurgical, Cutting & Coagulation &… 18
- GCJ Laparoscope, General & Plastic Surgery 14
- KCT Sterilization Wrap Containers, Trays… 13
- JXG Shunt, Central Nervous System And Components 13
- KWQ Appliance, Fixation, Spinal Intervertebral… 11
- HCH Clip, Aneurysm 10
- GAM Suture, Absorbable, Synthetic, Polyglycolic… 7
- GWG Endoscope, Neurological 7
- JWH Prosthesis, Knee, Patellofemorotibial… 6
- FRG Wrap, Sterilization 6
- HBE Drills, Burrs, Trephines & Accessories… 5
- HCI Applier, Aneurysm Clip 5
- MNI Orthosis, Spinal Pedicle Fixation 4
- HWC Screw, Fixation, Bone 4
- FZP Clip, Implantable 4
- HRX Arthroscope 3
- MNH Orthosis, Spondylolisthesis Spinal Fixation 3
- GAW Suture, Nonabsorbable, Synthetic… 3
- HAW Neurological Stereotaxic Instrument 3
- GXN Plate, Cranioplasty, Preformed, Non-Alterable 3
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K242762 | Aesculap Aicon® Series Container SystemKCT · Traditional | 05/13/2025SE |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetJXG · Traditional | 12/16/2024SE |
| K223596 | SQ.line KERRISONHAE · Traditional | 06/29/2023SE |
| K214041 | Aesculap AICON ContainerKCT · Traditional | 12/30/2022SE |
| K211572 | Aesculap Slim Clip ApplierHCI · Traditional | 12/13/2021SE |
| K203739 | ELAN 4 Electro Motor SystemHBE · Traditional | 08/24/2021SE |
| K202391 | Dir 800IZI · Traditional | 01/21/2021SE |
| K203461 | Aesculap Caiman 12 Seal and Cut Technology SystemGEI · Special | 12/18/2020SE |
| K202938 | Aesculap Caiman 5 Seal and Cut Technology SystemGEI · Special | 10/30/2020SE |
| K202124 | Aesculap PAS-Port Proximal Anastomosis SystemFZP · Special | 09/02/2020SE |
| K200950 | Ventricular CatheterJXG · Special | 05/08/2020SE |
| K192056 | JJ Series Container SystemKCT · Traditional | 03/27/2020SE |
| K193582 | SterilContainer S2 SystemKCT · Traditional | 03/17/2020SE |
| K192266 | M. Blue Adjustable Shunt SystemJXG · Traditional | 11/21/2019SE |
| K183203 | ELAN 4 ToolsHBE · Traditional | 08/09/2019SE |
| K190174 | Miethke Shunt System GAV 2.0 and SA 2.0 ValvesJXG · Traditional | 07/05/2019SE |
| K182414 | Aesculap® SterilContainer(TM) S2 SystemKCT · Traditional | 07/05/2019SE |
| K183180 | Caiman 5 MarylandGEI · Traditional | 03/12/2019SE |
| K182527 | ELAN 4 ToolsHBE · Traditional | 01/19/2019SE |
| K182032 | SterilContainer S SystemKCT · Traditional | 12/21/2018SE |
| K172907 | ELAN 4 Air Motor SystemHBB · Traditional | 11/09/2018SE |
| K172709 | ELAN 4 Electro Motor System ToolsHBE · Traditional | 10/17/2018SE |
| K180914 | Aesculap Slim Clip ApplierHCI · Traditional | 04/17/2018SE |
| K180321 | Aesculap Optilene Nonabsorbable SutureGAW · Special | 03/07/2018SE |
| K170683 | Aesculap Video Assisted Thoracic Surgery (VATS) INstrumentsGCJ · Traditional | 02/20/2018SE |
| K172850 | SterilContainer with PrimeLine Pro LidKCT · Special | 11/17/2017SE |
| K173271 | Aesculap Slim Clip Applier ForcepsHCI · Special | 11/10/2017SE |
| K171001 | Monosyn Quick Synthetic Absorbable Surgical SutureGAM · Traditional | 10/23/2017SE |
| K162815 | SterilContainer S SystemKCT · Traditional | 07/13/2017SE |
| K170661 | Novosyn Quick Absorbable SutureGAM · Traditional | 06/08/2017SE |
| K161853 | proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable…JXG · Traditional | 02/27/2017SE |
| K152960 | ELAN 4 Motor SystemHBC · Traditional | 07/22/2016SE |
| K160393 | AdTecGCJ · Special | 05/26/2016SE |
| K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureGAR · Traditional | 02/17/2016SE |
| K151865 | PremiPatch PTFE PledgetDXZ · Traditional | 10/27/2015SE |
| K151242 | SterilContainer SKCT · Traditional | 10/09/2015SE |
| K143729 | SterilContainer SKCT · Traditional | 08/18/2015SE |
| K151858 | Caiman Seal and Cut TechnologyGEI · Special | 07/21/2015SE |
| K151696 | Caiman Seal and Cut TechnologyGEI · Special | 07/20/2015SE |
| K142970 | SterilContainer S SystemKCT · Traditional | 07/08/2015SE |
| K141687 | Aesculap - Meithke Progav 2.0 Adjustable Shunt SystemJXG · Traditional | 04/02/2015SE |
| K142315 | MINOP Disposable Introducer 26FGWG · Special | 11/14/2014SE |
| K133890 | Aesculap Optilene Nonabsorbable SutureGAW · Traditional | 07/15/2014SE |
| K140343 | Aesculap Histoacryl, Histoacryl Blue and Histoacryl Flexible Topical Skin, Adhesive with…MPN · Traditional | 05/13/2014SE |
| K140839 | Caiman Seal and Cut TechnologyGEI · Special | 04/28/2014SE |
| K131500 | Yasargil Aneurysm Clips and Clip AppliersHCH · Traditional | 01/24/2014SE |
| K122791 | Lyoplant OnlayGXQ · Traditional | 06/04/2013SE |
| K121976 | Aesculap Histoacryl Flexible Topical Skin AdhesiveMPN · Traditional | 05/17/2013SE |
| K130596 | Caiman Seal and Cut TechnologyGEI · Special | 03/22/2013SE |
| K123102 | Sovereign MiniGCJ · Special | 01/03/2013SE |
| K122734 | Aesculap Novosyn Absorbable SutureGAM · Traditional | 12/18/2012SE |
| K122353 | Crainfix 2 Titanium Clamp SystemGXN · Special | 08/30/2012SE |
| K120559 | Aesculap-Meithke Prosa Adjustable Shunt SystemJXG · Traditional | 05/24/2012SE |
| K112671 | Sterilcontainer SystemKCT · Special | 05/04/2012SE |
| K111959 | Aesculap Histoacryl and Histoacryl Blue Topical Skin AdhesiveMPN · Traditional | 02/06/2012SE |
| K110206 | Aesculap- Meithke Shunt SystemJXG · Traditional | 10/27/2011SE |
| K110695 | Bipolar HF DeviceGEI · Traditional | 06/28/2011SE |
| K103003 | Aesculap- Meithke Progav Programmable Shunt SystemJXG · Special | 11/09/2010SE |
| K091692 | Aesculap PEEK CraniofixGXR · Traditional | 08/12/2010SE |
| K101937 | Hybrid Trocar SystemGCJ · Special | 08/11/2010SE |
| K102081 | Endoscopic Clip SystemFZP · Special | 08/06/2010SE |
| K093493 | Aesculap Sterilcontainer SFRG · Traditional | 07/27/2010SE |
| K100876 | Aesculap Monomax Absorbable SutureNWJ · Traditional | 07/14/2010SE |
| K093649 | Aesculap Sterilcontainer SFRG · Traditional | 05/11/2010SE |
| K081031 | Endoscopic Clip Appliers with Clip MagazineFZP · Special | 05/05/2008SE |
| K073168 | Aesculap Primeline Container Ltd.KCT · Traditional | 04/28/2008SE |
| K080753 | Aesculap Endoscopic Clip SytemFZP · Special | 04/02/2008SE |
| K062327 | Modification to S4 Spinal SystemNKB · Special | 03/14/2007SE |
| K062085 | S4 Spinal SystemNKB · Special | 03/02/2007SE |
| K062012 | S4 Cervical Occipital Plate Spinal SystemNKB · Traditional | 02/09/2007SE |
| K062009 | Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TJXG · Traditional | 01/17/2007SE |
| K063017 | Aesculap Sternumfix Sternal Closure SystemJDQ · Traditional | 12/27/2006SE |
| K062684 | Excia Total Hip System 36MM Ceramic HeadLZO · Special | 11/22/2006SE |
| K062413 | Aesculap Pneumatic KerrisonHAD · Traditional | 11/21/2006SE |
| K062510 | Aesculap Sterilcontainer SystemFRG · Traditional | 11/17/2006SE |
| K062406 | Aesculap Neuro PattiesHBA · Special | 09/15/2006SE |
| K060762 | Aesculap PEEK Vertebral Body Replacement SystemMQP · Traditional | 09/14/2006SE |
| K061699 | ExciaLWJ · Special | 08/18/2006SE |
| K061344 | Excia Total Hip System Lateral OffsetJDI · Special | 08/02/2006SE |
| K061424 | Celsite/ Celsite Concept, Access PortsLJT · Traditional | 07/31/2006SE |
| K061704 | Optilene MeshFTL · Special | 07/19/2006SE |
| K061135 | Minop Disposable Introducer 10F, Model ME010; 19F, Model ME019GWG · Traditional | 07/11/2006SE |
| K060707 | Aesculap Bipolar Acetabular CupKWY · Traditional | 05/31/2006SE |
| K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic HeadLZO · Special | 05/26/2006SE |
| K053579 | Columbus Ultra Congruent (Uc) Tibial Insert/Gliding SurfaceJWH · Special | 05/17/2006SE |
| K060492 | Aesculap Craniofacial Plate and ScrewJEY · Traditional | 04/07/2006SE |
| K060528 | Aesculap Trelon Nonabsorbable Multifilament Polyamide Surgical SutureGAR · Special | 03/28/2006SE |
| K060437 | Excia Total Hip System with U-CapMEH · Special | 03/22/2006SE |
| K053389 | Aesculap Sterilcontainer SystemFRG · Traditional | 02/15/2006SE |
| K053390 | Columbus (CR) Total Knee SystemJWH · Special | 02/06/2006SE |
| K060152 | Modification to S4 Spinal SystemMNI · Special | 02/03/2006SE |
| K053526 | Microspeed Uni Motor SystemHBC · Special | 01/18/2006SE |
| K053158 | Optilene Mesh LPFTL · Traditional | 01/18/2006SE |
| K050979 | S4 Spinal SystemMNI · Traditional | 07/27/2005SE |
| K050813 | Abc 2 ScrewKWQ · Special | 05/04/2005SE |
| K050752 | Aesculap Orthopilot 2 Tha V 2.0HAW · Special | 04/27/2005SE |
| K050804 | Modification to: Spectrumtm Cervical Spinal SystemKWQ · Special | 04/11/2005SE |
| K042344 | Excia Total Hip SystemLWJ · Abbreviated | 03/16/2005SE |
| K041623 | Reusable Sterilcontainer Filter Model #JK090FRG · Traditional | 12/13/2004SE |
| K043041 | Aesculap T-Bar Aneurysm Clips (Titanium & Phynox)HCH · Special | 12/09/2004SE |
| K043079 | Bicontact Hip System with U-CapMEH · Special | 12/08/2004SE |
| K040865 | Aesculap Sterrad 100S Compatable SterilcontainerFRG · Traditional | 12/06/2004SE |
| K040191 | Bicontact Hip Stem and Femoral HeadLPH · Traditional | 08/25/2004SE |
| K040864 | Craniofix and CRANIOFIX2 Titanium Clamp SystemGXN · Traditional | 06/17/2004SE |
| K040017 | Abc Caudal and Cranial Extension Plate (E-Plate)KWQ · Special | 05/14/2004SE |
| K040080 | Aesculap Absorbable CraniofixGXR · Traditional | 03/31/2004SE |
| K032108 | Search Evolution (LC) Total Knee System (Porous Coated)MBH · Abbreviated | 01/15/2004SE |
| K030367 | Columbus (PS)JWH · Traditional | 08/21/2003SE |
| K032198 | Aesculap Yasargil Aneurysm Clip Phynox Booster ClipHCH · Special | 08/20/2003SE |
| K032059 | Modification to Macs Modular Anterior Construct SystemKWQ · Special | 07/25/2003SE |
| K031216 | Monoplus Poly-P-Dioxanone Monofilament Absorbable Surgical SutureNEW · Traditional | 07/17/2003SE |
| K031303 | Aesculap-Miethke Shunt System Gravity Assisted Valve (Gav)JXG · Special | 06/04/2003SE |
| K031286 | Safil and Safil Quick Synthetic Absorbable Surgical SutureGAM · Special | 05/29/2003SE |
| K031008 | Aesculap Neuro Patties, Neurosorb 4, 6, and 75 (Green & White)HBA · Traditional | 05/09/2003SE |
| K030556 | Steelex Electrode SetLDF · Traditional | 04/22/2003SE |
| K024349 | Aesulap Kopitnik Avm Microclips and ApplierHCH · Traditional | 03/24/2003SE |
| K030698 | Aesculap - Miethke Shunt System W/ Nph-DsvJXG · Special | 03/20/2003SE |
| K023411 | Steelex Sternum SetGAQ · Traditional | 12/19/2002SE |
| K023788 | Columbus (CR) Total Knee SystemJWH · Special | 12/13/2002SE |
| K022672 | Columbus Total Knee System (CR)JWH · Traditional | 11/08/2002SE |
| K022942 | CraniocutHBE · Traditional | 10/21/2002SE |
| K021327 | Orthopilot Hto ModuleHAW · Traditional | 07/25/2002SE |
| K021313 | Search Evolution Total Knee SystemJWH · Traditional | 07/22/2002SE |
| K020728 | Miethke Shunt SystemHCA · Special | 04/05/2002SE |
| K013569 | Orthopilot 2HAW · Traditional | 04/04/2002SE |
| K014207 | Reposable Instrument System, Models MF001-MF083GEI · Traditional | 03/21/2002SE |
| K014172 | Nelson Electrosurgical Unit, Model GN640GEI · Traditional | 03/19/2002SE |
| K014149 | Paediscope, Model # P010A and PF011AGWG · Traditional | 03/18/2002SE |
| K011030 | Aesculap -Miethke Shunt SystemJXG · Traditional | 03/01/2002SE |
| K011556 | Macs Hma Anterior Spinal Stabilization SystemKWQ · Traditional | 11/16/2001SE |
| K012986 | Bipolar Irrigation ForcepsGEI · Special | 10/03/2001SE |
| K012201 | Premicron Nonabsorbable PET Surgical SutureGAT · Traditional | 09/19/2001SE |
| K011102 | Anterior Cruciate Ligament (Acl) Instrument SystemHWC · Traditional | 08/03/2001SE |
| K011372 | Aesculap, Inc. Safil Quick Synthetic Absorbable Surgical SutureGAM · Traditional | 08/01/2001SE |
| K012219 | Scalpfix Clip SystemHBO · Special | 07/31/2001SE |
| K011375 | Aesculap, Inc., Monosyn Synthetic Absorbable Surgical SutureGAM · Traditional | 06/29/2001SE |
| K003759 | Aesculap Spiegelberg Brain Pressure MonitorGWM · Traditional | 06/28/2001SE |
| K010752 | Aesculap's Modular Endoscopic Instruments for GynecologyKNF · Traditional | 06/11/2001SE |
| K002824 | Macs Modular Anterior Construct SystemKWQ · Traditional | 05/08/2001SE |
| K003740 | Miaspas Minitta Anterior Micro Surgical Transthoracic Approach InstrumentationHRX · Traditional | 04/27/2001SE |
| K003463 | Socon Spinal SystemMNH · Special | 04/11/2001SE |
| K003965 | MRI Safe InstrumentsGEA · Traditional | 03/16/2001SE |
| K003612 | Microspeed Ec Motorsystem GD650/GD653HBC · Traditional | 02/20/2001SE |
| K003608 | Sovereign Bipolar Instruments for GynecologyHGI · Traditional | 02/20/2001SE |
| K003519 | Yasargil Permanent Aneurysm ClipsHCH · Traditional | 01/29/2001SE |
| K002871 | Modification to Yasargil Aneurysm ClipsHCH · Special | 10/13/2000SE |
| K001080 | Spine System EvolutionKWP · Traditional | 06/29/2000SE |
| K001330 | Sovereign Bipolar InstrumentsGEI · Traditional | 05/30/2000SE |
| K000486 | Abc Cervical Plating SystemKWQ · Traditional | 04/14/2000SE |
| K000021 | Aesculap Bone WaxMTJ · Traditional | 03/24/2000SE |
| K993551 | Socon Spinal SystemMNH · Traditional | 01/13/2000SE |
| K992053 | Aesculap Vascular InstrumentsDXC · Traditional | 01/13/2000SE |
| K991223 | Absorbable Surgical Gut Suture, Plain and Chronic and Softcat Absorbable Surgical Gut…GAL · Traditional | 04/30/1999SE |
| K990090 | Dafilon Nonabsorbable Polyamide Surgical SutureGAR · Traditional | 03/22/1999SE |
| K990089 | Silkam Nonabsorbable Silk Surgical SutureGAP · Traditional | 03/15/1999SE |
| K984109 | Aesculap Axial Clip ApplierHCI · Traditional | 02/12/1999SE |
| K990088 | Synthofil Nonabsorbable PET Surgical SutureGAT · Traditional | 02/10/1999SE |
| K984124 | Aesculap Xenon Light SourceFSS · Traditional | 02/01/1999SE |
| K983758 | Yasargil Titanium Aneurysm ClipsHCH · Traditional | 12/18/1998SE |
| K983365 | Aesculap Minop SystemGWG · Traditional | 12/18/1998SE |
| K982914 | Aesculap Spine System Evolution: Additional ComponentsMNI · Traditional | 10/02/1998SE |
| K980484 | Aesculap Spine System EvolutionMNI · Traditional | 10/02/1998SE |
| K982623 | Aesculap Needlescopic Instrument SystemGCJ · Traditional | 09/30/1998SE |
| K980686 | Aesculap Hilan Motor SystemHBB · Traditional | 09/02/1998SE |
| K980121 | Aesculap Spine System Additional ComponentsKWP · Traditional | 06/10/1998SE |
| K980704 | Safil Synthetic Absorbable Surgical SutureGAM · Traditional | 05/11/1998SE |
| K980703 | Premilene Nonabsorbable Polypropylene Surgical SutureGAW · Traditional | 05/04/1998SE |
| K974706 | Aesculap Abc Cervical Plating SystemKWQ · Traditional | 03/13/1998SN |
| K972332 | Aesculap Craniofix Titanium Clamp SystemGXN · Traditional | 01/16/1998SE |
| K973736 | Aesculap Hilan Motor SystemHWE · Traditional | 12/29/1997SE |
| K970851 | Lyoplant Dura Substitute(Various)GXQ · Traditional | 12/09/1997SE |
| K970050 | Yasargil Titanium Aneurysm Clips (Ftxxxt)HCH · Traditional | 11/26/1997SE |
| K971310 | Aesculap Jet Irrigation SystemGEI · Traditional | 07/18/1997SE |
| K970285 | Aesuclap Socon Spinal SystemMNH · Traditional | 06/25/1997SE |
| K970549 | Titanium Alloy Bone ScrewsHWC · Traditional | 04/30/1997SN |
| K964281 | Aesculap Angled NeuroendoscopesGWG · Traditional | 04/21/1997SE |
| K970541 | Aesculap Modular Monopolar ElectrodesGEI · Traditional | 03/28/1997SE |
| K962493 | Endoscopic Clip ApplierOCW · Traditional | 09/11/1996SE |
| K960470 | Neuro-PatchGXQ · Traditional | 05/10/1996SE |
| K960473 | Aesculap Power System HandpieceGET · Traditional | 03/07/1996SE |
| K954394 | Aesculap Ventriculoscope SystemGWG · Traditional | 03/07/1996SE |
| K954652 | Aesculap Endosccopic Spine InstrumentsHRX · Traditional | 02/14/1996SN |
| K953968 | Aesculap Power Systems (Elan-E & Microtron)HWE · Traditional | 02/05/1996SE |
| K953720 | Aesculap Caspar Plate & Screw System for Anterior Cervical FusionKWQ · Traditional | 11/02/1995SN |
| K953446 | Aesculap Bipolar CordsGEI · Traditional | 09/29/1995SE |
| K952524 | Aesculap Biopolar CoagulatorGEI · Traditional | 06/29/1995SE |
| K942730 | Aesculap LaparoscopesHET · Traditional | 04/25/1995SE |
| K943603 | Aesculap Laparoscopic Ancillary DevicesHET · Traditional | 03/29/1995SE |
| K940970 | Yasargil, Caspar, Vario Clip AppliersHCI · Traditional | 01/24/1995SE |
| K944955 | Aesculap Thoracoscopic InstrumentsKNS · Traditional | 11/09/1994SE |
| K944467 | Aesculap Manual Laparoscopic InstrumentsGCJ · Traditional | 10/03/1994SE |
| K936269 | Caspar Titanium Alloy Bone ScrewsKWQ · Traditional | 08/15/1994SN |
| K935243 | Aesculap Flexible Trocar Instrument SetGCJ · Traditional | 07/21/1994SE |
| K940207 | Titanium Alloy Bone ScrewsHWC · Traditional | 07/12/1994SE |
| K941239 | Aesculap NeuroendoscopeGWG · Traditional | 07/11/1994SE |
| K942053 | Aesculap Interchangeable Trocar Instrument SetGCJ · Traditional | 06/10/1994SE |
| K933330 | Aesculap Manual Endoscopic InstrumentsGCJ · Traditional | 06/07/1994SE |
| K940936 | Aesculap Endoscopic InstrumentsGEI · Traditional | 04/19/1994SE |
| K941024 | Aesculap Trocar CollarGCJ · Traditional | 04/13/1994SE |
| K936186 | Aesculap Skin Graft MesherFZW · Traditional | 03/10/1994SE |
| K940208 | Aesculap Accu-DermatomeGFD · Traditional | 02/24/1994SE |
| K933294 | Mis Clean-Set Flushing Unit and AccessoriesFPB · Traditional | 02/09/1994SE |
| K923705 | Aesculap Craniofacial Titanium Plates and ScrewsJEY · Traditional | 02/01/1994SE |
| K932346 | Aesculap Manual Endoscopic InstrumentsGCJ · Traditional | 01/07/1994SE |
| K934724 | Aesculap Trocar Instrument SetFBQ · Traditional | 12/23/1993SE |
| K933834 | Aesculap Rigid EndoscopesGCJ · Traditional | 12/20/1993SE |
| K933201 | Aesculap Trocar Instrument SetGCS · Traditional | 09/13/1993SE |
| K933076 | Aesculap Manual Endoscopic InstrumentsGCJ · Traditional | 09/10/1993SE |
| K922576 | Aesculap Manual Endoscopic InstrumentsGEI · Traditional | 06/10/1993SE |
| K922797 | Aesculap Trocar Instrument SetGCJ · Traditional | 03/30/1993SE |
| K922272 | Yasargil Aneurysm ClipsHCH · Traditional | 09/15/1992SE |
| K913730 | Aesculap Titanium Bone PlatesKWQ · Traditional | 03/12/1992SE |
| K913765 | Yasargil Aneurysm Clips, ModificationHCH · Traditional | 03/11/1992SE |
| K913262 | Aesculap Surgical AccessoriesGEY · Traditional | 12/30/1991SE |
| K913415 | Aesculap Titanium Bone ScrewsHWC · Traditional | 10/29/1991SN |
| K904435 | Ventrofil Tension Relief Suture SetKGS · Traditional | 08/29/1991SE |
| K904859 | Motor Driven Extirpation InstrumentsHRX · Traditional | 03/15/1991SE |
| K905143 | Skin MarkerFZZ · Traditional | 02/06/1991SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1485-2026 Class II | Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog…There is the potential for the length of the trocar shaft to be too long. | 01/15/2026Open, Classified |
| Z-0312-2026 Class II | Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog…It was determined there is the potential of silicone fragments detaching from the yellow sealing component. | 09/24/2025Open, Classified |
| Z-0311-2026 Class II | Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog…It was determined there is the potential of silicone fragments detaching from the yellow sealing component. | 09/24/2025Open, Classified |
| Z-0310-2026 Class II | Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number:…It was determined there is the potential of silicone fragments detaching from the yellow sealing component. | 09/24/2025Open, Classified |
| Z-0309-2026 Class II | Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER…It was determined there is the potential of silicone fragments detaching from the yellow sealing component. | 09/24/2025Open, Classified |
| Z-0027-2026 Class II | AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG… | 08/18/2025Open, Classified |
| Z-0026-2026 Class II | AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG… | 08/18/2025Open, Classified |
| Z-1312-2025 Class II | Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps…The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | 01/31/2025Open, Classified |
| Z-1311-2025 Class II | Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD…The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | 01/31/2025Open, Classified |
| Z-1310-2025 Class II | Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig Artery Forceps…The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | 01/31/2025Open, Classified |
| Z-1309-2025 Class II | Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps…The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | 01/31/2025Open, Classified |
| Z-1308-2025 Class II | Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy…The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | 01/31/2025Open, Classified |
| Z-2139-2024 Class II | Aeos Robotic Digital Microscope, Product Code: PV010Possibility of the robotic arm to drop more than 10cm from its original position after pressing the… | 05/13/2024Open, Classified |
| Z-1247-2024 Class II | DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures.The sterile blister packaging may be damaged, and sterility may be compromised. | 01/09/2024Open, Classified |
| Z-1246-2024 Class II | DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic…The sterile blister packaging may be damaged, and sterility may be compromised. | 01/09/2024Open, Classified |
| Z-1245-2024 Class II | DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic…The sterile blister packaging may be damaged, and sterility may be compromised. | 01/09/2024Open, Classified |
| Z-1244-2024 Class II | DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.The sterile blister packaging may be damaged, and sterility may be compromised. | 01/09/2024Open, Classified |
| Z-1243-2024 Class II | DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic…The sterile blister packaging may be damaged, and sterility may be compromised. | 01/09/2024Open, Classified |
| Z-0867-2024 Class II | MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE…Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R… | 12/29/2023Open, Classified |
| Z-0866-2024 Class II | MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC…Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R… | 12/29/2023Open, Classified |
| Z-1043-2016 Class II | Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision…Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem implant… | 11/30/2015Terminated |
| Z-0566-2016 Class II | Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in…AAG received a customer complaint that corrosion had been found by a hospitals central sterile service… | 11/17/2015Terminated |
| Z-0448-2016 Class II | Tray Set containing multiple instruments and may contain the flexible bone awl, flexible…The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay… | 11/10/2015Terminated |
| Z-0424-2016 Class II | Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG These instruments are…The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay… | 11/10/2015Terminated |
| Z-0423-2016 Class II | Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG: These instruments…The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay… | 11/10/2015Terminated |
| Z-0422-2016 Class II | Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These…The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay… | 11/10/2015Terminated |
| Z-2326-2015 Class II | S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System…A FW103R torque wrench that was improperly reassembled after reprocessing caused a screw to break during… | 07/07/2015Terminated |
| Z-1012-2015 Class II | Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended…Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. The… | 12/17/2014Terminated |
| Z-0814-2015 Class III | Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to…Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing patients'… | 11/11/2014Terminated |
| Z-0502-2015 Class II | The Dual Switch Valve is used for fluid drainage from the ventricles into the…Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System, Dual Switch Valve, due to incorrect… | 10/24/2014Terminated |
| Z-2024-2014 Class II | Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide…Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4… | 06/13/2014Terminated |
| Z-1676-2014 Class II | Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The…AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the… | 04/21/2014Terminated |
| Z-0989-2014 Class II | Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system…The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L. | 12/23/2013Terminated |
| Z-0623-2014 Class II | Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the HiLAN and…Certain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possible failure… | 12/09/2013Terminated |
| Z-0361-2014 Class II | Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)The trial insertion instrument may disassemble during use due to a potentially weak weld on then trial… | 09/20/2013Terminated |
| Z-0492-2014 Class II | Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible. | 09/19/2013Terminated |
| Z-0479-2014 Class II | Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is…Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop… | 09/10/2013Terminated |
| Z-0031-2014 Class II | UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during…Changes were implemented to the UNITRAC instructions for use to ensure safe use and potentially extend the… | 07/16/2013Terminated |
| Z-1806-2013 Class II | ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body…Aesculap Implant Systems, LLC initiated a recall of the Aesculap Prospace PEEK 5 degree Implant - 8 x 8.5 x… | 06/18/2013Terminated |
| Z-0887-2013 Class II | Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting…The bipolar energy did not stop after release of the foot pedal. | 01/18/2013Terminated |
| Z-0805-2013 Class II | Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and…The deflector may not move freely on the ventricular catheter. The deflector comes pre-positioned at the 5… | 06/04/2012Terminated |
| Z-0082-2013 Class II | Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)The manufacturer informed the recalling firm of a potential laser marking error in size identification on… | 05/09/2012Terminated |
| Z-3014-2011 | Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha…Aesculap Implant Systems received a notification from the manufacturer, Aesculap, AG of a fractured CoCr… | 07/19/2011Terminated |
| Z-1474-2011 | Aesculap MicroSpeed Uni Control Box, Part #GD670 Intended for high speed cutting…Potential safety issue in that the control box can misinterpret the information sent from the low speed… | 11/22/2010Terminated |
| Z-0709-2008 | Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT430T, Casper Applier F/Std…Breakage: the inner rod of the applier may corrode and break | 11/01/2007Terminated |
| Z-0708-2008 | Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT420T, Casper Applier F/Mini…Breakage: the inner rod of the applier may corrode and break | 11/01/2007Terminated |