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 Brand History Cross-category recall lookup by company
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

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.

Clear
DateProductReasonClassFirm
May 26, 2021 Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used wi... Physician Order Form (PL-15400-00 Nov 2018) distributed is discontinued due to the text 'Refil... Class II Flowonix Medical Inc
Dec 24, 2019 Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusio... A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... Class II Flowonix Medical Inc
Dec 24, 2019 Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an impla... A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... Class II Flowonix Medical Inc
Dec 24, 2019 Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantab... A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... Class II Flowonix Medical Inc
Dec 24, 2019 US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implan... A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... Class II Flowonix Medical Inc
Dec 24, 2019 Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantab... A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... Class II Flowonix Medical Inc
Dec 24, 2019 Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusio... A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... Class II Flowonix Medical Inc
Mar 21, 2019 Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal in... The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout,... Class II Flowonix Medical Inc
Mar 21, 2019 Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion. The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout,... Class II Flowonix Medical Inc
Mar 21, 2019 Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, u... The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout,... Class II Flowonix Medical Inc
Mar 21, 2019 Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No... The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout,... Class II Flowonix Medical Inc
Mar 21, 2019 Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion. The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout,... Class II Flowonix Medical Inc
May 22, 2017 PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Nu... Flowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump ... Class II Flowonix 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.