Browse Device Recalls
875 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 875 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 875 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, S... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, ... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22mm, Ne... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, ... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, S... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, ... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, N... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, S... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 1... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Sep 24, 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, ... | Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated t... | Class II | Zimmer Biomet, Inc. |
| Aug 14, 2020 | Dual Mobility Vivacit-E Bearing, Model Number 110031009 | The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size... | Class II | Zimmer Biomet, Inc. |
| May 5, 2020 | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X35MM, Item Nu... | There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... | Class II | Zimmer Biomet, Inc. |
| May 5, 2020 | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X50MM, Item Nu... | There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... | Class II | Zimmer Biomet, Inc. |
| May 5, 2020 | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X40MM, Item Nu... | There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... | Class II | Zimmer Biomet, Inc. |
| May 5, 2020 | Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X50MM, Item Num... | There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... | Class II | Zimmer Biomet, Inc. |
| May 5, 2020 | Vital MIS Spinal Fixation system implants VITAL MIS TAB BREAKER, Item Number ... | There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... | Class II | Zimmer Biomet, Inc. |
| May 5, 2020 | Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X40MM, Item Num... | There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... | Class II | Zimmer Biomet, Inc. |
| May 5, 2020 | Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X45MM, Item Num... | There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... | Class II | Zimmer Biomet, Inc. |
| May 5, 2020 | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X40MM, Item Nu... | There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... | Class II | Zimmer Biomet, Inc. |
| May 5, 2020 | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X50MM, Item Nu... | There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... | Class II | Zimmer Biomet, Inc. |
| May 5, 2020 | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X45MM, Item Nu... | There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... | Class II | Zimmer Biomet, Inc. |
| May 5, 2020 | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X55MM, Item Nu... | There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... | Class II | Zimmer Biomet, Inc. |
| May 5, 2020 | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X40MM, Item Nu... | There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... | Class II | Zimmer Biomet, Inc. |
| May 5, 2020 | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X35MM, Item Nu... | There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... | Class II | Zimmer Biomet, Inc. |
| May 5, 2020 | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X55MM, Item Nu... | There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... | Class II | Zimmer Biomet, Inc. |
| May 5, 2020 | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM, Item Nu... | There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... | Class II | Zimmer Biomet, Inc. |
| May 5, 2020 | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X45MM, Item Nu... | There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... | Class II | Zimmer Biomet, Inc. |
| May 5, 2020 | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X35MM, Item Nu... | There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... | Class II | Zimmer Biomet, Inc. |
| May 5, 2020 | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X55MM, Item Nu... | There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... | Class II | Zimmer Biomet, Inc. |
| May 5, 2020 | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X40MM, Item Nu... | There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... | Class II | Zimmer Biomet, Inc. |
| May 5, 2020 | Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X60MM, Item Num... | There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... | Class II | Zimmer Biomet, Inc. |
| May 5, 2020 | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X45MM, Item Nu... | There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... | Class II | Zimmer Biomet, Inc. |
| May 5, 2020 | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Nu... | There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... | 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.