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

237 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 237 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 237 FDA device recalls.

Clear
DateProductReasonClassFirm
Sep 27, 2016 TRANSPAC¿ IV MONITORING KIT NEONATAL, 24", DISPOSABLE TRANSDUCER, 30 ML SQUEE... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 TRIFURCATED DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP, Item... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 TRIFURCATED MK W/03ML FLUSH DEVICE FOR UNIV. HEALTH SYSTEM, Item No. 46097-62... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 Transpac¿ IV Bifurcated Monitoring Kit w/03 ml Squeeze Flush Device, PT Tubin... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 CATH LAB KIT, Item No. 46096-25 The Transpac Disposable Straight Pressure Tr... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 24, 2016 Tego Connector, Item No. D1000, NM1000 The Tego¿ Needle Free Access Device... ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices. Class II ICU Medical, Inc.
Aug 10, 2016 Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37 Product... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Adm... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Single Monitoring Kit with 30mL Flush Device, Item No. 46073-38 Product ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with 2 SafeSet Reservoir and 2 Blood Sampling Port... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 m... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sam... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Triple Line SafeSet Kit with 03mL Flush Device, Item No. 46076-27 Produc... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservo... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75 Product... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Sque... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with 03 ml Squeeze Flush, SafeSet Reservoir, 2 Nee... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and N... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing, Reser... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syri... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: The Tran... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 SafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: T... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, D... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 4... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Rese... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Monitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Mar 8, 2016 Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R The... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU Medical, Inc.
Mar 8, 2016 Diana Automated Compounding System, Diana Onco 3xx, Item No. ASN303 The Dian... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU Medical, Inc.
Mar 8, 2016 Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU Medical, Inc.
Mar 8, 2016 Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 The... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU Medical, Inc.
Mar 8, 2016 Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No.... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU Medical, Inc.
Mar 8, 2016 Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Dia... ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... Class II ICU 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.