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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 Expression MR IBP DPT Kit, I/N, Box 20, Item No. 989803194641 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 HEART KIT W/03ML FLUSH DEVICE FOR ST. JOSEPHS HOSP., Item No. 46076-59 The 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 Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 4259... 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 CARDIAC KIT WITH 03 ml FLUSH DEVICE, Item No. 46099-57 The Transpac Disposab... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 ICN TRANSDUCER KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 460... 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 84" Arterial Pressure Tubing, Reservoir... 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/Waste Bag System, 3 Port "OFF" Manifold (600 psi), Transpac¿ 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¿ 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 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 Transpac¿ IV Monitoring Kit w/Safeset" Blood Sampling Port and 03 ml Squeeze ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 TP4 Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush and Needlele... 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¿ 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 LEFT HEART KIT FOR PORTLAND ADVENTIST HOSP., Item No. 46066-13 The Transpac ... 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 KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORTS,... 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 TRANSDUCER, 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 TRIPLE PRESSURE KIT W/03ML FLUSH DEVICE FOR UNIV. OF IOWA, Item No. 46091-56 ... 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/Arterial 84" Safeset" Reservoir, 03 ml Squeeze ... 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 CARLE CLINIC, Item No. 46087-37 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 TRANSPAC¿ IV MONITORING KIT WITH 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 Transpac¿ w/Safeset Reservoir, Squeeze 03 ml Flush and Needleless Valve, 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, Item No. 42582-06 The Tra... 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 Elkhart Hosp., Item No. 46078-17 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 PERFUSION KIT W/03ML FLUSH DEVICE FOR NE REGIONAL MED. CTR, Item No. 46097-33... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Sep 27, 2016 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 ART/CVP KIT W/03ML FLUSH DEVICE FOR MILWAUKEE CHILDRENS HOSP., Item No. 46059... 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 UNIV. OF NEW MEXICO, Item No. 46085... 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 DISPOSABLE TRANSDUCER KIT W/03ML FLUSH DEVICE FOR JOHNS HOPKINS/B... 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 WITH 03ML FLUSH DEVICE FOR ALL CHILDRENS HOSP., Item No. 46076... 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 "OFF" MANIFOLD, w/HP STOPCOCK, WASTE BAG ASSY, 10 cc SYRINGE & AD SETS... 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 MEDICAL COLLEGE OF GA, Item No. 46080-... 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 CVL MONITORING KIT W/03ML FLUSH DEVICE FOR YALE NEW HAVEN HOSP., 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 Neonate Kit With 30 ml Flush Device For Driscoll Foundation For Children, Ite... 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, 12", 3 STOPCOCKS, DISPOSABLE TRANSDUCER... 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 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.

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.