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Browse Device Recalls

13 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 13 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 13 FDA device recalls.

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DateProductReasonClassFirm
Mar 22, 2024 Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the... Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potenti... Class II EBI, LLC
Mar 22, 2024 20" Lead Wires, Replacement Part Number: 1067724-2 Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potenti... Class II EBI, LLC
Mar 22, 2024 Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for ... Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potenti... Class II EBI, LLC
Mar 22, 2024 48" Lead Wires, Replacement Part Number: 1067724-4 Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potenti... Class II EBI, LLC
Nov 11, 2014 Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-53... A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleev... Class II Ebi, Llc
Oct 8, 2014 Cypher MIS Screw System-The system includes screws, various types and sizes o... Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is ... Class II Ebi, Llc
May 15, 2014 Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrumen... The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure. Class II Ebi, Llc
Sep 24, 2013 Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Steri... Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off dur... Class II Ebi, Llc
Aug 22, 2013 BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System... Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are ge... Class II Ebi, Llc
Aug 13, 2013 Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Sc... Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System. Class II Ebi, Llc
Apr 9, 2013 Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an in... Several complaints were recorded regarding one of the three screws driving through the cage of th... Class II Ebi, Llc
Feb 7, 2013 Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-50017... Increased risk of failure at the driver tip during screw insertion or removal. Class II Ebi, Llc
Sep 29, 2012 Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178 Broken screw insertor hardness was measured and found to be below the acceptable limits. Class II Ebi, 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.