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

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

Clear
DateProductReasonClassFirm
Mar 9, 2017 Hemotherm CE, model 400CE, Heater-Cooling Device Improperly rated fuses were used in the manufacture of the device. Class II Cincinnati Sub-Zero Products Inc
Nov 7, 2016 The Hemotherm 400CE 115v, containing power board p/n 39945 The device may not maintain water flow or temperature control. Class II Cincinnati Sub-Zero Products Inc
Jan 7, 2015 Cold Therapy Pad - cold water circulating pad, one unit per package. The pa... Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead t... Class II Cincinnati Sub-Zero Products Inc
Jan 8, 2014 115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or ... The incorrect voltage component was placed into the device during manufacturing. This may make th... Class II Cincinnati Sub-Zero Products Inc
Sep 3, 2013 Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 M... During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Opera... Class II Cincinnati Sub-Zero Products Inc
May 15, 2013 Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data E... During a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-1... Class II Cincinnati Sub-Zero Products 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.