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Browse Device Recalls

1,125 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,125 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 1,125 FDA device recalls.

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DateProductReasonClassFirm
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 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 11, 2020 Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01... The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS... Class II 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.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, 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 4.5X45MM, 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 5.5X35MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
Apr 17, 2020 Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regene... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-P... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 ... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 ... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 M... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibia... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 1... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ M... Potential presence of elevated endotoxin levels that exceed the specification limit 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.