CooperSurgical, Inc.
Medical device manufacturer in Trumbull, CT.
42510(k) clearances
3PMA approvals
85recalls
Device types
- HIH Hysteroscope (And Accessories) 5
- HEW Culdoscope (And Accessories) 4
- LKF Cannula, Manipulator/Injector, Uterine 4
- HET Laparoscope, Gynecologic (And Accessories) 3
- KNS Unit, Electrosurgical, Endoscopic (With Or… 3
- MQF Catheter, Assisted Reproduction 3
- MQE Needle, Assisted Reproduction 3
- HEE Set, Anesthesia, Paracervical 2
- MQL Media, Reproductive 2
- HEX Colposcope (And Colpomicroscope) 2
- MQG Accessory, Assisted Reproduction 1
- PWB Fetal Head Elevator 1
- HHW Pessary, Vaginal 1
- PUB Accessory, Assisted Reproduction, Exempt 1
- MPO Infant Heel Warmer (Chemical Heat Pack) 1
- HDW Diaphragm, Contraceptive (And Accessories) 1
- KNF Coagulator-Cutter, Endoscopic, Unipolar… 1
- HIB Speculum, Vaginal, Nonmetal 1
- HGI Electrocautery, Gynecologic (And Accessories) 1
- GCX Apparatus, Suction, Operating-Room, Wall… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261083 | Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum…MQG · Traditional | 08/19/2026SE |
| K243799 | Fetal PillowPWB · Traditional | 08/29/2025SE |
| K250438 | CooperSurgical Milex® PessariesHHW · Traditional | 04/11/2025SE |
| K223064 | ALLY II Uterine Positioning System (UPS)LKF · Special | 10/28/2022SE |
| K201086 | Advincula Delineator Uterine ManipulatorHEW · Special | 05/21/2020SE |
| K200038 | Endosee SystemHIH · Special | 02/05/2020SE |
| K191020 | G210 InviCell Plus with SignipHy pH monitoringPUB · Traditional | 01/14/2020SE |
| K191291 | Wallace Dual Lumen Oocyte Recovery SystemMQE · Special | 06/12/2019SE |
| K190639 | Endosee SystemHIH · Special | 05/15/2019SE |
| K182959 | Wallace Dual Lumen Oocyte Recovery SystemMQE · Traditional | 05/10/2019SE |
| K183020 | Endosee SystemHIH · Traditional | 01/31/2019SE |
| K180429 | Advincula Delineator Uterine ManipulatorHEW · Special | 03/14/2018SE |
| K173731 | SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit…MQL · Traditional | 03/02/2018SE |
| K170660 | Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaHIH · Traditional | 07/13/2017SE |
| K170560 | SAGE Vitrification Kit and SAGE Vitrification Warming KitMQL · Special | 04/04/2017SE |
| K151845 | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)MPO · Traditional | 03/18/2016SE |
| K153092 | Ally Uterine Positioning SystemLKF · Special | 12/21/2015SE |
| K143650 | CooperSurgical Advincula Delineator Uterine ManipulatorHEW · Traditional | 07/21/2015SE |
| K143415 | Air Bubble Based Infuser (ABBI)LKF · Traditional | 02/26/2015SE |
| K141523 | Ally UpsLKF · Traditional | 11/25/2014SE |
| K140754 | Cooper Surgical Leisegang Colposcope SystemHEX · Traditional | 10/23/2014SE |
| K063223 | Milex Contraceptive Diaphragm, Omniflex Diaphragms, Arcing Diaphragms, Wideseal DiaphragmsHDW · Traditional | 01/23/2008SE |
| K021237 | Coopersurgical Laparoscopic InstrumentsHET · Traditional | 04/10/2003SE |
| K023930 | Coopersurgical Oocyte Recovery NeedlesMQE · Traditional | 01/22/2003SE |
| K990350 | Wallace CATHETERS-18CM, Model 1816; 23CM, Model 1816N; 23CM, Model 2316MQF · Traditional | 07/26/1999SE |
| K990349 | Wallace Malleable STYLET-18CM, Model 1816ST, Wallace Malleable STYLET-23CM, Model 1816NSTMQF · Traditional | 07/26/1999SE |
| K990348 | Wallace Trial Transfer Catheter, Model TT 1816NMQF · Traditional | 07/26/1999SE |
| K990852 | Coopersurgical Infrared CoagulatorKNS · Traditional | 06/11/1999SE |
| K990850 | Coopersurgical Coagulator for Tattoo RemovalKNS · Traditional | 06/01/1999SE |
| K990855 | Coopersurgical Infrared Coagulator for ENTKNS · Traditional | 03/30/1999SE |
| K972630 | Coopersurgical Digital Colposcopy SystemHEX · Traditional | 02/02/1998SE |
| K971836 | Verrescope, Light Cable - Light Source AdaptorHET · Traditional | 11/07/1997SE |
| K971838 | Micro ElectrodesKNF · Traditional | 11/05/1997SE |
| K971837 | Verres Needle, Cannula for M820, Cannula W/Trumpet Valve for M 820HET · Traditional | 08/06/1997SE |
| K954311 | Koh Colpotomizer SystemHEW · Traditional | 11/19/1996SE |
| K951898 | Versa-VuHIB · Traditional | 12/11/1995SE |
| K952483 | Leep System 1000HGI · Traditional | 10/06/1995SE |
| K914108 | RG27-SERIES Resectoscope and AccessoriesHIH · Traditional | 03/19/1992SE |
| K910377 | Coopersurgical Model 6080 Smoke Evacuator SystemGCX · Traditional | 04/19/1991SE |
| K910254 | Diagnostic Hysteroscopy Redikit (TM)HHE · Traditional | 04/18/1991SESD |
| K910253 | Leep RedikitHEE · Traditional | 04/18/1991SE |
| K910252 | Potocky Neddle (TM) Disposable Injection NeedleHEE · Traditional | 03/04/1991SE |
PMA approvals
- P160047 MARA Vapor System, MARA Vapor Probe Procedure Kit, MARA Vapor Generator and MARA Vapor Generator Accessory Kit · 06/14/2017 · 36 supplements
- P000032 Her Option (TM) Uterine Cryoblation Therapy System · 04/20/2001 · 38 supplements
- P990016 Mccue Cubaclinical Ultrasonic Bone Sonometry System with Cubaplus+ V4.1.0 · 01/07/2000 · 2 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-3140-2026 | INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing…Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly… | 08/11/2026Open, Classified |
| Z-3139-2026 | INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing…Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly… | 08/11/2026Open, Classified |
| Z-2137-2025 Class II | Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System…The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the… | 06/11/2025Open, Classified |
| Z-2136-2025 Class II | Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience KitThe HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the… | 06/11/2025Open, Classified |
| Z-2135-2025 Class II | HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in…The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the… | 06/11/2025Open, Classified |
| Z-0692-2025 Class II | Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number:…The warming surfaces or incubator well temperatures of the listed products may exceed the desired set… | 11/15/2024Open, Classified |
| Z-0691-2025 Class II | Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software…The warming surfaces or incubator well temperatures of the listed products may exceed the desired set… | 11/15/2024Open, Classified |
| Z-0690-2025 Class II | Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055…The warming surfaces or incubator well temperatures of the listed products may exceed the desired set… | 11/15/2024Open, Classified |
| Z-0689-2025 Class II | Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054…The warming surfaces or incubator well temperatures of the listed products may exceed the desired set… | 11/15/2024Open, Classified |
| Z-0688-2025 Class II | Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074…The warming surfaces or incubator well temperatures of the listed products may exceed the desired set… | 11/15/2024Open, Classified |
| Z-0687-2025 Class II | Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065…The warming surfaces or incubator well temperatures of the listed products may exceed the desired set… | 11/15/2024Open, Classified |
| Z-3189-2024 Class II | Stainless Steel Sims Uterine Sound, Part Number 64-601During the manufacturing process the devices were laser-marked with the incorrect part number. | 07/31/2024Open, Classified |
| Z-3188-2024 Class II | Silver-Plated Copper Sims Uterine Sound, Part Number 64-600During the manufacturing process the devices were laser-marked with the incorrect part number. | 07/31/2024Open, Classified |
| Z-3298-2024 Class II | Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of…Low concentration of sodium pyruvate in the wash could compromise gamete development | 02/16/2024Open, Classified |
| Z-3297-2024 Class II | Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of…Low concentration of sodium pyruvate in the wash could compromise gamete development | 02/16/2024Open, Classified |
| Z-3296-2024 Class II | Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa…Low concentration of sodium pyruvate in the wash could compromise gamete development | 02/16/2024Open, Classified |
| Z-1089-2024 Class II | global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100…The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues… | 12/20/2023Open, Classified |
| Z-0985-2024 Class II | Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box…Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays. | 08/29/2023Open, Classified |
| Z-1348-2023 Class II | Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo…It has come to CooperSurgical's attention that the affected Product may contain a medium other than the… | 02/13/2023Open, Classified |
| Z-1044-2023 Class II | BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage…The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the… | 12/15/2022Open, Classified |
| Z-0223-2023 Class II | NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540Firm has received 11 complaints involving a loose or detached metal clips, including 3 cases where the metal… | 10/20/2022Open, Classified |
| Z-1823-2022 Class II | Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop…There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of… | 08/12/2022Open, Classified |
| Z-1822-2022 Class II | Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop…There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of… | 08/12/2022Open, Classified |
| Z-1421-2022 Class II | LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055There was translation error in the Spanish version of the IFU where the Spanish version instructs the user… | 06/13/2022Open, Classified |
| Z-1108-2022 Class II | VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a…Products in this lot may have compromised barrier seals, introducing a risk to sterility. | 04/01/2022Open, Classified |
| Z-0504-2024 Class II | CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For…Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component… | 03/31/2022Open, Classified |
| Z-0503-2024 Class II | Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during…Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component… | 03/31/2022Open, Classified |
| Z-0502-2024 Class II | Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during…Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component… | 03/31/2022Open, Classified |
| Z-0263-2022 Class II | Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05WXXX | 09/29/2021Open, Classified |
| Z-0262-2022 Class II | Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate… | 09/29/2021Open, Classified |
| Z-0261-2022 Class II | Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate… | 09/29/2021Open, Classified |
| Z-0260-2022 Class II | LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate… | 09/29/2021Open, Classified |
| Z-0259-2022 Class II | LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate… | 09/29/2021Open, Classified |
| Z-0258-2022 Class II | LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate… | 09/29/2021Open, Classified |
| Z-0257-2022 Class II | LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate… | 09/29/2021Open, Classified |
| Z-2307-2021 Class II | Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers…Units are displaying output readings that differ from the measurements taken using a Gas Analyzer. When the… | 06/30/2021Terminated |
| Z-1847-2021 Class II | CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable…The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package… | 04/30/2021Terminated |
| Z-1686-2021 Class II | The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices…The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm… | 04/23/2021Open, Classified |
| Z-1152-2021 Class II | Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem…The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a… | 01/21/2021Terminated |
| Z-0100-2021 Class II | MediCult Vitrification Cooling Media, Model Number 12284001FThere is a discrepancy between the printing on the Product Tyvek label of the individual component… | 09/08/2020Terminated |
| Z-2498-2020 Class II | COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm…Mislabeled: Printing on the top web or Tyvek lid of the individual product blister tray indicating that it… | 06/03/2020Terminated |
| Z-2112-2020 Class II | CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators. | 04/09/2020Terminated |
| Z-1713-2020 Class III | Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units)…Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years. | 02/28/2020Terminated |
| Z-0798-2020 Class II | ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The…Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5). | 12/13/2019Terminated |
| Z-0602-2020 Class II | Quantam 2000 Electrosurgical Generator, Part number 909075-05W.Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to… | 10/16/2019Terminated |
| Z-0601-2020 Class II | Quantam 2000 Electrosurgical Generator, Part number 909075-05.Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to… | 10/16/2019Terminated |
| Z-0600-2020 Class II | Quantam 2000 Electrosurgical Generator, Part number 909075.Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to… | 10/16/2019Terminated |
| Z-0029-2020 Class III | Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, &…The touchpad may not work properly after cleaning. | 09/05/2019Terminated |
| Z-2545-2019 Class III | LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.Discrepancy between the correct expiration dates on the individual pouches inside the boxes and incorrect… | 08/19/2019Terminated |
| Z-2364-2019 Class II | TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The…The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other heat… | 07/08/2019Terminated |
| Z-2057-2019 Class II | LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 &…The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal. | 06/18/2019Terminated |
| Z-1978-2019 Class II | Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750SC-KE30 The…The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when… | 06/14/2019Terminated |
| Z-1977-2019 Class II | Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The…The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when… | 06/14/2019Terminated |
| Z-1840-2019 Class II | LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION…2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate… | 04/23/2019Terminated |
| Z-1367-2019 Class II | ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent | 03/27/2019Terminated |
| Z-3278-2018 Class II | Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The…There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of… | 09/04/2018Terminated |
| Z-0098-2019 Class II | Colpo-Pneumo Occluder, Part CPO-6The seal of the sterile pouch may be compromised, thereby increasing the risk of infection. | 09/04/2018Terminated |
| Z-1879-2018 Class II | Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151Products have been packaged with an incorrect product size. | 03/12/2018Terminated |
| Z-1584-2018 Class II | 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count)…Products have been packaged with the wrong Trocar length type. | 03/12/2018Terminated |
| Z-1131-2018 Class II | Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB…The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe | 10/06/2017Terminated |
| Z-2054-2017 Class II | CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part…The current secondary packaging, a box, incorrectly states that the product is latex free. The product is… | 04/10/2017Terminated |
| Z-2851-2016 Class III | Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium…Products contain international package insert and not the correct USA package insert | 08/25/2016Terminated |
| Z-2850-2016 Class III | Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium…Products contain international package insert and not the correct USA package insert | 08/25/2016Terminated |
| Z-1054-2016 Class II | Milex Arcing Diaphragm Size 95; Model Number: MXWS95The products have been identified to contain an incorrect size Diaphragm. | 02/16/2016Terminated |
| Z-0253-2016 Class III | MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage:…The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packaging. While… | 09/14/2015Terminated |
| Z-0105-2016 Class III | CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical…Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials… | 09/01/2015Terminated |
| Z-2147-2015 Class II | Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and…Product marketed without a 510(k) | 07/06/2015Terminated |
| Z-2098-2015 Class II | Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The…Incorrect expiration date on outer carton kit label | 06/19/2015Terminated |
| Z-1814-2015 Class II | MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80A diaphragm size 80 labeled box was incorrectly packaged with a size 85. | 05/20/2015Terminated |
| Z-1727-2015 Class II | Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and…Design of device may expose user to injury to fingers or body parts | 05/18/2015Terminated |
| Z-1824-2015 Class II | McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior…Small sized specula were incorrectly packaged in printed bags for the medium sized speculum | 04/13/2015Terminated |
| Z-1630-2015 Class II | Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic…The pad printing around the suture entry holes on the 15mm Suture Guide included in the kit may not have… | 03/20/2015Terminated |
| Z-1450-2015 Class II | WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with…Internal gas line may malfunction causing the line to burst under pressure. | 03/09/2015Terminated |
| Z-1239-2015 Class II | CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02Incorrect size printed on the Milex Pessary Kit packaging label | 02/09/2015Terminated |
| Z-1301-2015 Class II | NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal…Products without expiration date have the remote potential for minor burn | 01/26/2015Terminated |
| Z-1300-2015 Class II | MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel…Products without expiration date have the remote potential for minor burn | 01/26/2015Terminated |
| Z-1299-2015 Class II | Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant…Products without expiration date have the remote potential for minor burn | 01/26/2015Terminated |
| Z-1298-2015 Class II | CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer…Products without expiration date have the remote potential for minor burn | 01/26/2015Terminated |
| Z-0488-2015 Class III | Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION…The product has been identified to contain an incorrect curette type. | 10/27/2014Terminated |
| Z-0484-2015 Class II | CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of…Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop… | 10/27/2014Terminated |
| Z-0208-2015 Class III | CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01…Incorrect expiration date printed on the MILEX PESSARY KIT packaging | 09/30/2014Terminated |
| Z-0207-2015 Class III | CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01…Incorrect expiration date printed on the MILEX PESSARY KIT packaging | 09/30/2014Terminated |
| Z-2570-2014 Class II | CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/…Unsealed pouches. | 07/03/2014Terminated |
| Z-1782-2014 Class II | Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model…Sterility of the device may be compromised due to unsealed pouch | 05/13/2014Terminated |
| Z-1397-2015 Class II | CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private…Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification | 05/01/2013Terminated |