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Browse Device Recalls

590 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 590 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 590 FDA device recalls.

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DateProductReasonClassFirm
Sep 27, 2016 ARTERIAL PRESSURE KIT W/03ML FLUSH DEVICE FOR LEBONHEUR CHILDRENS 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 5 Port "OFF" Manifold w/TRANSPAC¿ IV, Item No. 46100-29 The Transpac Disposa... 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 Reservoir, 24" Tubing,03 ml Intraflo¿ ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 CARDIAC CATH LAB KIT FOR PRESBYTERIAN INTERCOMMUNITY HOSP., Item No. 46095-33... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 4 Port "ON" Manifold (600 psi) w/4 ft. Transpac¿ IV, Item No. 46300-14NS The... 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 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.
Sep 27, 2016 4 Port "ON" Manifold (600 psi) w/4 ft. Transpac¿ IV, Item No. 46300-14NS The... 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 Left Heart Kit w/3 Port Manifold "OFF" (600 psi), Transpac¿ IV, Wast... 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 Disposable Transducer w/Stopcocks w/o Cap and Covers, Item No. 4... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 NEONATAL KIT WITH 30ML FLUSH DEVICE FOR YALE-NEW HAVEN HOSP., Item No. 46068-... 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 W/03ML Flush Device, Mounts, Reservoir & TP4, Item No. 46099-24 The... 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 2 BONDED STOPCOCKS, 72", DISPOSABLE TRANSDUC... 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/4 Way Stopcock, 3 Way Stopcock and 24" Arterial... 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 KIT WITH 03ML FLUSH DEVICE FOR UNIVERSITY OF MICHIGAN 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 TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS AND WITHOUT COVERS, 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 CATH LAB KIT w/3 PORT "OFF" MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEE... 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 ANESTHESIA KIT W/03ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46... 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 DISPOSABLE TRANSDUCER MONITORING KIT WITH BONDED STOPCOCK AND 3... 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 TRIFURCATED MONITORING KIT, 84" 3 DISPOSABLE TRANSDUCERS WITH 2 ... 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 KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-21 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 LEFT HEART KIT, Item No. AG8052-NS The Transpac Disposable Straight Pressure... 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, 72" 2 DISPOSABLE TRANSDUCERS, with 2 ... 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 TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK WI... 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 KIT W/SAFESET" AND 03ML FLUSH DEVICE FOR O.H.S.U., Item No. 46080-38 ... 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/03 ml Squeeze Flush Device, Arterial Safeset" R... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 ADD-ON DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS 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 Transpac¿ IV Monitoring Kit, 60", 03 ml Squeeze Flush Device, 2 3 Way Stopcoc... 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 CONCORD HOSP., Item No. 46091-13 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 MK W/03ML FLUSH DEVICE FOR UNIV OF PENN. HEALTH SYSTEMS, Item No. 4608... 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 FOR ALBERT EINSTEIN M.C., Item No. 46047-19 The Transpac Dispos... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 RIGHT HEART KIT FOR NC BAPTIST HOSPITAL, Item No. 46066-34 The Transpac Disp... 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 FOR BAPTIST M. C., Item No. 46078-52 The Transpac Disposable St... 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 48", 2 Disposable Transducers, 2 03 ml... 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/03 ml Squeeze Flush and Macrodrip, Item No. 461... 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 #2 FOR MARY HITCHCOCK MEM. HOSP., Item No. 46057-18 The Transpa... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 PTCA KIT W/03ML FLUSH DEVICE FOR WILLIAMSPORT HOSP, Item No. 46095-22 The Tr... 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 PRESSURE KIT WITH 03ML FLUSH DEVICE FOR METHODIST M.C. OF ILLINOIS, 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 M.K. WITH 03ML FLUSH DEVICE FOR DRISCOLL FOUNDATION CHILDRENS 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 Transpac¿ IV Trifurcated Monitoring Kit w/84" Safeset" Reservoir, 03 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, 84", 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 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 RIGHT HEART CATH LAB KIT FOR BAPTIST MEM. HOSP., Item No. 46071-40 The Trans... 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 72 INCH, 2 DISPOSABLE TRANSDUCERS, 2 3... 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", WITH DISPOSABLE TRANSDUCER, 30 ML... 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 TRIFURCATED MONITORING KIT 72", 3 DISPOSABLE TRANSDUCERS, 3 3 ML... 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 DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK, 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 Transpac¿ 4 kit w/72" Macrodrip¿ Admin Set, Item No. 46099-77 The Transpac D... 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 TRANSPAC¿ 4 WITH 03ML FLUSH DEVICE FOR BUFFALO GENERAL 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 OPEN HEART KIT WITH 03ML FLUSH DEVICE FOR FLETCHER ALLEN HEALTH CARE, Item No... 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.