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Browse Device Recalls

68 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 68 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 68 FDA device recalls.

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DateProductReasonClassFirm
May 4, 2018 Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463 Laser etching which indicates whether the device is in compression or distraction mode appears ... Class II Stryker GmbH
Apr 27, 2018 Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Femoral Nail, RIGHT T2 GTN ¿9x320 mm, Product Number 18510932S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Femoral Nail, LEFT T2 GTN ¿10x360 mm, Product Number 18501036S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Femoral Nail, A/R T2 Femur ¿15x240 mm, Product Number 18251524S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Femoral Nail, A/R T2 Femur ¿10x340 mm, Product Number 18251034S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Femoral Nail, RIGHT T2 GTN ¿14x460 mm, Product Number 18511446S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Femoral Nail, LEFT T2 GTN ¿14x300 mm, Product Number 18501430S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Femoral Nail, A/R, R1500 T2 Femur ¿12x360 mm, Product Number 18281236S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Apr 27, 2018 Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S The manufacturer has discovered that potentially out-of-specification products may have left the ... Class II Stryker GmbH
Mar 12, 2018 Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of ... The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labe... Class II Stryker GmbH

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.