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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.

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DateProductReasonClassFirm
Sep 27, 2016 CATH LAB KIT w/3 PORT ''ON'' MANIFOLD, WASTE BAG, TP4, SYRINGES & 30 ml BURET... 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 SALINA REGIONAL, Item No. 46092-34 The Transpac Disposable ... 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/TP4, 03 ml Squeeze Flush, Blue Stripe Pressure Tubing, 3 Way... 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 60 INCH, 3 DISPOSABLE TRANSDUCERS, 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 w/03 ml Squeeze Flush Device, Arteria... 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 w/2 Port "OFF" Manifold (600 psi), 72" Spike Set, 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 CATH LAB KIT #3 FOR MARY HITCHCOCK HOSP., Item No. 46063-37 The Transpac Dis... 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, WASTE BAG, SYRINGE & TP4, Item No. AG789... 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" w/03 ml Squeeze Flush Device, Red... 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 GENESIS HEALTH CARE, Item No. 46089-74 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 2 PORT RIGHT "OFF" MANIFOLD w/ADMIN SET 72" PT, 3 WAY STOPCOCK, TP4 & 1 WAY 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 Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pre... 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, 72", 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 MONITORING KIT WITH 03ML FLUSH DEVICE FOR NYU MED CTR, Item No. 46094-37 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 KIT WITH 03ML FLUSH DEVICE FOR MEMORIAL HEALTHCARE, Item No. 46090-0... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 PEDIATRIC ARTERIAL KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. 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 KIT W/03ML FLUSH DEVICE & SAFESET, Item No. 46099-18 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 Cath Lab Kit w/3 Port "ON" Manifold, 03 ml Flush Device, Waste Bag, HPT, Syri... 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¿ IV Monitoring Kit w/03 ml Squeeze Flush Device, Red 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 Trifurcated Transpac¿ IV w/03 ml Squeeze Flush Device, 130" Safeset" Reservoi... 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/30ML Flush Device for Monongalia General Hosp, Item No. 46090-... 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 WITH BONDED STOPCOCK, 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 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.

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.