Browse Device Recalls

2,560 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,560 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 2,560 FDA device recalls in IN.

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DateProductReasonClassFirm
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.
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.
Sep 4, 2020 Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050 Product not properly being aligned with the adequate gamma sterilization group and result in the... Class II Biomet, Inc.
Sep 4, 2020 Biomet Regenerex Primary Taper Cap Item Number 141269 Product not properly being aligned with the adequate gamma sterilization group and result in the... Class II 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.