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

18 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 18 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 18 FDA device recalls.

Clear
DateProductReasonClassFirm
Dec 15, 2025 Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape... Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I SunMed Holdings, LLC
Dec 15, 2025 Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Mode... Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I SunMed Holdings, LLC
Dec 15, 2025 Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer ... Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I SunMed Holdings, LLC
Dec 15, 2025 Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape... Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I SunMed Holdings, LLC
May 15, 2025 Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700... The impacted tape was manufactured with incorrect information on the tape. Incorrect values are p... Class I SunMed Holdings, LLC
May 1, 2025 Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Mano... Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient p... Class I SunMed Holdings, LLC
Oct 11, 2023 Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multipl... A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... Class II SunMed Holdings, LLC
Oct 11, 2023 Curaplex manual resuscitators with integrated manometer, multiple accessory c... A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... Class II SunMed Holdings, LLC
Oct 11, 2023 Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple... A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... Class II SunMed Holdings, LLC
Oct 11, 2023 Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple ... A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... Class II SunMed Holdings, LLC
Oct 11, 2023 Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multipl... A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... Class II SunMed Holdings, LLC
Oct 11, 2023 Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, mult... A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... Class II SunMed Holdings, LLC
Oct 11, 2023 Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multi... A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... Class II SunMed Holdings, LLC
Oct 11, 2023 Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, m... A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... Class II SunMed Holdings, LLC
Oct 11, 2023 Medline manual resuscitators with integrated manometer, multiple accessory co... A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... Class II SunMed Holdings, LLC
Dec 22, 2022 AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size ... There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed... Class II SunMed Holdings, LLC
Dec 22, 2022 Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size RE... There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed... Class II SunMed Holdings, LLC
Sep 8, 2022 Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91 The kits are being recalled due to a lack of sterility of a spare needle contained within the kit... Class II SunMed Holdings, LLC

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.