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Browse Device Recalls

14 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 14 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 14 FDA device recalls.

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DateProductReasonClassFirm
May 15, 2020 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be... Lack of pouch seal. Product is labelled as sterile. Class II TeDan Surgical Innovations LLC
May 15, 2020 PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usa... Lack of pouch seal. Product is labelled as sterile. Class II TeDan Surgical Innovations LLC
May 15, 2020 PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Us... Lack of pouch seal. Product is labelled as sterile. Class II TeDan Surgical Innovations LLC
May 15, 2020 PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intende... Lack of pouch seal. Product is labelled as sterile. Class II TeDan Surgical Innovations LLC
May 15, 2020 PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usa... Lack of pouch seal. Product is labelled as sterile. Class II TeDan Surgical Innovations LLC
May 15, 2020 PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intende... Lack of pouch seal. Product is labelled as sterile. Class II TeDan Surgical Innovations LLC
May 15, 2020 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be... Lack of pouch seal. Product is labelled as sterile. Class II TeDan Surgical Innovations LLC
Jul 16, 2019 Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; R... There was incorrect raw material used in the production of the identified lot. Class II TeDan Surgical Innovations LLC
Apr 1, 2019 Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical interverteb... Incorrect part description contained on an additional label placed on the packaging: A 14mm lengt... Class II Zimmer Biomet, Inc.
Feb 18, 2019 DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: The... The items identified for recall are labeled as sterile. However, the manufacturer has found that ... Class II TeDan Surgical Innovations LLC
Feb 18, 2019 D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR... The items identified for recall are labeled as sterile. However, the manufacturer has found that ... Class II TeDan Surgical Innovations LLC
Feb 18, 2019 DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: The... The items identified for recall are labeled as sterile. However, the manufacturer has found that ... Class II TeDan Surgical Innovations LLC
Feb 18, 2019 D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR... The items identified for recall are labeled as sterile. However, the manufacturer has found that ... Class II TeDan Surgical Innovations LLC
Jun 11, 2012 Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold un... This letter is to notify you that several of our sterile screw products are being voluntarily rec... Class II Tedan Surgical Innovations Llc

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.