Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

Clear
DateProductReasonClassFirm
Jan 3, 2025 Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer... Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorr... Class II XTANT Medical Holdings, Inc
Aug 21, 2024 Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-... Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not h... Class II XTANT Medical Holdings, Inc
Nov 28, 2023 Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws lab... Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorr... Class II XTANT Medical Holdings, Inc
Dec 29, 2021 X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System. The proximal opening of the inserts exhibit an out of specification condition which would prevent... Class II XTANT Medical
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
May 12, 2020 Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591 The strike plate fractured off from the forceps inserter devices with minimal impaction or force ... Class II XTANT Medical
May 3, 2019 OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERIL... The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (... Class II XTANT MEDICAL INC
Dec 19, 2018 Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034... This recall has been initiated due to a change in packaging and sterilization method to address p... Class II XTANT MEDICAL INC
Apr 12, 2017 5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The produc... The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cob... Class II XTANT MEDICAL 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.