Browse Device Recalls
3,191 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,191 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 3,191 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 25, 2017 | ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a qu... | False susceptible results | Class II | BioMerieux SA |
| Apr 20, 2017 | Microfil Composite Instruments are packaged in an unsealed plastic sleeve, wh... | Microfil Composite Instruments were distributed with a sterile symbol on their packaging label in... | Class II | Almore International Inc |
| Apr 13, 2017 | ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative techn... | QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Fo... | Class II | BioMerieux SA |
| Apr 13, 2017 | Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE ... | Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles i... | Class II | Medtronic Sofamor Danek USA Inc |
| Apr 13, 2017 | ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative tec... | QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Fo... | Class II | BioMerieux SA |
| Apr 13, 2017 | Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gent... | Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek pac... | Class II | Zimmer Biomet, Inc. |
| Apr 10, 2017 | CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit an... | The current secondary packaging, a box, incorrectly states that the product is latex free. The pr... | Class II | CooperSurgical, Inc. |
| Mar 30, 2017 | AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cut... | Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cut... | Class II | Abbott Medical Optics Inc. (AMO) |
| Mar 29, 2017 | Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079. | Some of the individual unit packaging (pouches) may be missing the lot number an expiration date. | Class III | Teleflex Medical |
| Mar 27, 2017 | Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblag... | Alcon is initiating a Voluntary Medical Device Removal because the product supplier has stated th... | Class II | Alcon Research, Ltd. |
| Mar 16, 2017 | Ortho Basic Pack, part number AMS6459 Product packaged in a convenient ma... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189. Product packaged... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Eye Pack, part numbers WAL1085(B and WAL1085(C\ Product packaged in a conven... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Custom Tray, part numbers PSS1111 and PSS1111(A. Product packaged in a con... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Minor Operation Kit, part number AMS1530 Product packaged in a convenient ma... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a ... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a ... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a co... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | ENT Pack, part number AMS2727 Product packaged in a convenient manner for us... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Lasik Tray, part number DDS1045-2 Product packaged in a convenient manner fo... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Setup Pack, part number AMS3112(A Product packaged in a convenient manner fo... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Vitrectomy Pack, part number AMS4952 Product packaged in a convenient mann... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a c... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient mann... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | PRK Tray, part number DDS1044 Product packaged in a convenient manner for ... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient ... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, a... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 9, 2017 | OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individuall... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| Mar 9, 2017 | EYE KIT The Covidien Curity Oval Eye Pads are individually packaged and st... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| Mar 9, 2017 | POST-OPERATIVE OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads ... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| Mar 9, 2017 | POST-OP EYE TRAY The Covidien Curity Oval Eye Pads are individually packag... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| Mar 9, 2017 | OPHTHALMIC DRS TRAY The Covidien Curity Oval Eye Pads are individually pac... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| Mar 9, 2017 | OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually ... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| Mar 9, 2017 | CUSTOM CADAVER KIT The Covidien Curity Oval Eye Pads are individually packag... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| Feb 28, 2017 | Segmental fluted stem, 18x250mm bwd, Sterile, | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... | Class II | Zimmer Biomet, Inc. |
| Feb 28, 2017 | Tibial IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and acces... | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... | Class II | Zimmer Biomet, Inc. |
| Feb 28, 2017 | Fem IM Nail 14mmdx48cm right, Sterile, Rod, fixation, intramedullary and ac... | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... | Class II | Zimmer Biomet, Inc. |
| Feb 28, 2017 | Por fullct fem st 16x200mm, Sterile, | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... | Class II | Zimmer Biomet, Inc. |
| Feb 28, 2017 | Fem IM Nail 16mmdx48cm, Sterile, Rod, fixation, intramedullary and accessor... | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... | Class II | Zimmer Biomet, Inc. |
| Feb 28, 2017 | Segmental fluted stem, 17x250mm bwd, Sterile, Knee joint femorotibial meta/... | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... | Class II | Zimmer Biomet, Inc. |
| Feb 28, 2017 | Fem IM Nail 16mmdx50cm, Sterile, Rod, fixation, intramedullary and accessor... | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... | Class II | Zimmer Biomet, Inc. |
| Feb 28, 2017 | Segmental vss bowed 19x190mm, Sterile, Hip joint, metal/ceramic/polymer, se... | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... | Class II | Zimmer Biomet, Inc. |
| Feb 28, 2017 | Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and acce... | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... | Class II | Zimmer Biomet, Inc. |
| Feb 28, 2017 | Fem IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessor... | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... | Class II | Zimmer Biomet, Inc. |
| Feb 28, 2017 | Segmental malefemale taper, 200mm, Sterile, Rod, fixation, intramedullary a... | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... | Class II | Zimmer Biomet, Inc. |
| Feb 28, 2017 | Segmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation, intramedullary... | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... | Class II | Zimmer Biomet, Inc. |
| Feb 28, 2017 | Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and acce... | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... | Class II | Zimmer Biomet, Inc. |
| Feb 28, 2017 | Fem IM Nail 14mmdx50cm left, Sterile, Rod, fixation, intramedullary and acc... | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... | Class II | Zimmer Biomet, Inc. |
| Feb 28, 2017 | Fem IM Nail 16mmdx40cm, Sterile, Rod, fixation, intramedullary and accessor... | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... | Class II | Zimmer Biomet, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.