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

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
Jul 23, 2024 VariSoft Infusion Set, Single Use. Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) brand... Class II Unomedical A/S
Mar 5, 2024 Neria Soft Infusion Set, Product Code 507302, intravascular administration set Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been ... Class II Unomedical A/S
Oct 11, 2023 VariSoft infusion set, Model Number 1002830 The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported w... Class I Unomedical A/S
Oct 11, 2023 VariSoft infusion set, Model Number 1002827 The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported w... Class I Unomedical A/S
Oct 11, 2023 VariSoft infusion set, Model Number 1002828 The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported w... Class I Unomedical A/S
Jul 21, 2022 Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 10028... The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an ... Class II Unomedical A/S

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.