Browse Device Recalls
2,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,602 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 2,602 FDA device recalls in 2020.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 30, 2020 | COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant compo... | The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval... | Class II | Merz North America, Inc. |
| Sep 30, 2020 | VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: I... | Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiag... | Class II | Ortho Clinical Diagnostics Inc |
| Sep 30, 2020 | VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage... | Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiag... | Class II | Ortho Clinical Diagnostics Inc |
| Sep 30, 2020 | XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Steri... | Cervical Implants contain a label that incorrectly identifies the grade of titanium used. | Class III | XTANT Medical |
| Sep 29, 2020 | BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be us... | Due to a change in handle material and process, probe handle may crack. | Class II | Verathon, Inc. |
| Sep 29, 2020 | v|tome|x L Series non-destructive testing cabinet x-ray systems | It was discovered during testing of the v/tome/x L450 system s/n PA1790, that the pre-warning si... | Class II | Ge Inspection Technologies Llc |
| Sep 28, 2020 | VNS Therapy¿ AspireSR¿ Generator | Due to an extra digit being inadvertently added to the serial number of a subset of implantable p... | Class II | LivaNova USA Inc |
| Sep 26, 2020 | AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 us... | Mislabeling; It has been determined that some batteries were improperly labeled and may contain a... | Class III | Advanced Bionics, LLC |
| Sep 26, 2020 | AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 us... | Mislabeling; It has been determined that some batteries were improperly labeled and may contain a... | Class III | Advanced Bionics, LLC |
| Sep 25, 2020 | Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe P... | The device may be incorrectly laser marked as a right stem, when it should have been laser marked... | Class II | Exactech, Inc. |
| Sep 25, 2020 | Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Pl... | The device may be incorrectly laser marked as a right stem, when it should have been laser marked... | Class II | Exactech, Inc. |
| Sep 25, 2020 | QUIDEL Sofia SARS Antigen FIA IVD REF 20374 | Due to false positive results. | Class II | Quidel Corporation |
| Sep 25, 2020 | Osteosynthesis Compression Staple EasyClip | The device has the potential to release nickel above the acceptable margin of safety in pediatric... | Class II | Stryker GmbH |
| Sep 25, 2020 | Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". ... | Potential for the needle to detach from the cartridge after the bottom of the cartridge is twiste... | Class II | Cardinal Health 200, LLC |
| 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 | Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-3... | System does not include a drill guide. | Class II | RTI Surgical, Inc. (dba Pioneer Surgical Techno... |
| 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 | Yuno II Mobile Operating Table - Product Usage: support and position the pati... | Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and electronic parts expos... | Class II | Maquet Cardiovascular Us Sales, Llc |
| 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. |
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.