Browse Device Recalls
2,549 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,549 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 2,549 FDA device recalls in IN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Sep 4, 2020 | Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055 | Product not properly being aligned with the adequate gamma sterilization group and result in the... | Class II | Biomet, Inc. |
| Sep 4, 2020 | Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055 | Product not properly being aligned with the adequate gamma sterilization group and result in the... | Class II | Biomet, Inc. |
| Sep 3, 2020 | (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar C... | Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip sy... | Class II | Biomet, Inc. |
| Sep 2, 2020 | Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper A... | Product potentially being packaged without a taper adapter or baseplate. The package should conta... | Class II | Biomet, Inc. |
| Aug 31, 2020 | Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, ... | The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy ... | Class II | Cook Inc. |
| Aug 31, 2020 | Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-... | The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy ... | Class II | Cook Inc. |
| Aug 31, 2020 | BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001 | Potential for Fluid leaks within the instruments, creating an electrical short inside the power s... | Class II | Roche Diagnostics Operations, Inc. |
| Aug 31, 2020 | DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Nu... | Potential for Fluid leaks within the instruments, creating an electrical short inside the power s... | Class II | Roche Diagnostics Operations, Inc. |
| Aug 27, 2020 | Tina-quant Complement C4 ver.2, Catalog 05991994190 | Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for... | Class III | Roche Diagnostics Operations, Inc. |
| Aug 27, 2020 | Albumin Gen.2, Catalog 05166861190 | Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for... | Class III | Roche Diagnostics Operations, Inc. |
| Aug 20, 2020 | Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 063... | Recent internal verification studies found the current RF interference claim to no longer be met ... | Class II | Roche Diagnostics Operations, 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.