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 |
|---|---|---|---|---|
| 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 |
| Jan 25, 2017 | OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible O... | Mislabeling. The packaging labeled as left mandible contained a right mandible. | Class II | Matrix Surgical Holdings, LLC |
| Jan 25, 2017 | DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED W... | DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage p... | Class III | DeRoyal Industries Inc |
| Jan 20, 2017 | CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is Cav... | Metrex is recalling the CaviWipes Extra Large because they may have been contaminated during the ... | Class II | Metrex Research, LLC. |
| Jan 11, 2017 | Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, pa... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Stem Pack, part number AMS5166 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Hernia Pack, part number AMS3859 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Breast Recon Pack, part number AMS5698 Breast Recon Pack, part number AMS5698(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Bayview Abdominoplasty Pack, part number 009079-1 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Lower Extremity Pack, part number AMS4669 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Lap Gallbladder Pack, part number AMS3707 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Facial Plastic Pack, part number AMS3327(C | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Universal Pack, part number AMS2036 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Morris Lap Pack, part number PSS3199(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Angio Pack, part number AMS6711 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Brow Pack, part number PSS1785(C | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Extremity Pack-N Brunswick, part number PSS1866(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Plastic General Pack, part number AMS4215 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Facial Pack , part number AMS6501 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Dr. Landi EVLT Pack, part number AMS1483(E Dr. Landi EVLT Pack, part number ... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Dr Bragg Vein Tray - RX, part number 007912-8 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Plastic Kit, part number CMP1084(C | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Open Procedure Pack, part number AMS4596 Open Procedure Pack, part number AM... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Percutaneous Entry Kit, part number TVS4022(D Percutaneous Entry Kit , part ... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, 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.