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 |
|---|---|---|---|---|
| Nov 20, 2020 | Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin c... | Device has the potential for fracture during use. | Class II | Zimmer Biomet, Inc. |
| Nov 17, 2020 | Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbos... | Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU)... | 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. 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. 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, 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. 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. 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. 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. 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. 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. 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, 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, 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. 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. 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. 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. 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. 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, ... | 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. 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. 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, 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. 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, 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. 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. 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. 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. 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. 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. 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. 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. 32 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. 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. 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. 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, 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, ... | 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. 32mm, 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. 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. |
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.