Browse Device Recalls
3,264 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,264 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 3,264 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Feb 28, 2017 | Fem IM Nail 14mmdx50cm 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 | Fem IM Nail 16mmdx46cm, 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 | Por fullct fem st 15x200mm, Sterile, prosthesis, hip, semi-constrained, met... | 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 15mmdx48cm, 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 | Fem IM Nail 15mmdx46cm, 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 | Fem IM Nail 16mmdx42cm, 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 | Fem IM Nail 16mmdx44cm, 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 | Xl por st 25.5x220mm, bowed\, bowed, 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 18x200mm, 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 15mmdx50cm, 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, 15x250mm 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 | Segmental fluted stem, 16x250mm 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 | Segmental fluted stem, 19x190mm str, 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 | Segmental fluted stem, 18x190mm str, 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 | Xl por st 24.0x220mm, bowed, 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 | Segmental malefemale taper, 220mm, Sterile, Knee joint femorotibial meta/po... | 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 16mmdx38cm, 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 | Fem IM Nail 14mmdx48cm 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 | Segmental fluted stem, 17x190mm str, 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 | Por fullct fem st 17x200mm, Sterile, | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... | Class II | Zimmer Biomet, Inc. |
| Feb 23, 2017 | Manometer, 550 ml three-Way Stopcock; STERILE; | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Feb 23, 2017 | JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.)... | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Feb 23, 2017 | ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE; | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Feb 23, 2017 | JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.... | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Feb 23, 2017 | Thoracentesis/ Paracentesis Kit 10/CS; STERILE; | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Feb 23, 2017 | JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G ... | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Jan 25, 2017 | SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAI... | DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage p... | Class III | DeRoyal Industries 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.