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 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

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

Clear
DateProductReasonClassFirm
Jan 14, 2019 SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product U... In these units, the brake is usually released by gripping the drive handle and applied by letting... Class II Shimadzu Medical Systems Usa Com
Jan 14, 2019 TRINIAS for diagnostic imaging and interventional procedures in cardiac angio... Two issues: Event 1: Normal operation of the device is to power up the device in the morning, ... Class II Shimadzu Medical Systems Usa Com
Jan 14, 2019 BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is ... Normal operation of the device is to power up the device in the morning, register the first patie... Class II Shimadzu Medical Systems Usa Com
Jun 15, 2018 TRINIAS Digital Angiographic System intended to be used for cardiac angiograp... Due to a software issue the C-arm may unexpectedly moved when being moved to the park position an... Class II Shimadzu Medical Systems Usa Com
May 23, 2017 SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-20... Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. Class II Shimadzu Medical Systems Usa Com
May 23, 2017 SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ra... Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. Class II Shimadzu Medical Systems Usa Com
May 23, 2017 SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. Class II Shimadzu Medical Systems Usa Com

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.