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Browse Device Recalls

780 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 780 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 780 FDA device recalls.

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DateProductReasonClassFirm
Sep 27, 2016 QUAD TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUBBOCK HEART HOSP., Item No. ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 Double LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. 4607... 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 DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACROD... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 MONITORING KIT WITH 03ML FLUSH DEVICE FOR LEHIGH VALLEY HOSPITAL CENTER, 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 Transpac¿ IV Monitoring Kit w/Safeset 72" Pressure Tubing, Reservoir, 03 ml S... 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 w/03 ml Intraflo, 2 Port Manifold Right OFF Rotator and TP4, It... 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, 60", Disposable Transducer, 30 ML Intraflo¿ Flus... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 OPEN HEART KIT W/03ML FLUSH DEVICE FOR CUMBERLAND COUNTY HOSP., Item No. 4609... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 ARTERIAL SET-UP W/03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., Item No. 4606... 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, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH,... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 QUAD KIT WITH THREE TRANSPAC¿ AND 03ML FLUSH DEVICES FOR ST. FRANCIS HOSP., I... 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 w/4 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE, WASTE BASIN, SHARPST... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 PERFUSION KIT FOR UNIV. OF IOWA, Item No. 46091-51 The Transpac Disposable S... 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 , 60", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUS... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 Monitoring Kit #3 w/03 ml Flush Device for Childrens Hosp, Item No. 46010-34 ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 TRANSDUCER KIT FOR MEDICAL CTR. AT BOWLING GREEN, Item No. 46097-64 The Tran... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 BIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-20 Th... 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, 9", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH,... 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 w/3 Port "ON" Manifold (600 psi), Transpac¿ IV, 2 Admin Sets and... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 ART LINE KIT W/ 3ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46053-14 T... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 TRIPLE (3) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN.... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 SINGLE A LINE KIT CC5 W/03ML FLUSH DEVICE FOR ALBERT EINSTEIN M.C., Item No. ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 MONITORING KIT W/30 ML FLUSH DEVICE FOR EGLESTON HOSP., Item No. 46094-50 Th... 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, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, ... 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, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRO... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 KIT FOR UNIVERSITY OF MICH. MOTT CATH LAB, Item No. 46061-49 The Transpac Di... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 MONITORING KIT WITH 03ML FLUSH DEVICE FOR CHRIST HOSPITAL, Item No. 46054-42 ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 MONITORING KIT W/03ML FLUSH DEVICE FOR PITT CO. MEM. HOSP., Item No. 46076-19... 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 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.
Sep 15, 2016 SDMS (SenTec Digital Monitoring System) Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Modu... Class II SenTec AG
Aug 17, 2016 HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and... Foreign material found within the driveline connector of the HVAD Pump that could cause increased... Class I HeartWare, Inc
Aug 15, 2016 CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG5... Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Syst... Class II Biosense Webster, 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.

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.