Brand

Icu Medical Inc Recalls

441 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Icu Medical Inc.

441Total Recalls
20Critical
66.1MUnits Affected
Dec 19, 2025Most Recent
All Recalls

Every Icu Medical Inc Recall

Sorted by most recent. Click any recall for full details.

441 recalls
High RiskFDA
Icu Medical, Inc.
RIGHT HEART KIT FOR NC BAPTIST HOSPITAL, Item No. 46066-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascul...
Cardiac Devices·125 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
CATH LAB KIT FOR ALBERT EINSTEIN M.C., Item No. 46047-19 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular...
Surgical Devices·60 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRIPLE MK W/03ML FLUSH DEVICE FOR UNIV OF PENN. HEALTH SYSTEMS, Item No. 46088-08 The Transpac Disposable Straight Pressure Transducer (...
Surgical Devices·30 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
MONITORING KIT WITH 03ML FLUSH DEVICE FOR CONCORD HOSP., Item No. 46091-13 The Transpac Disposable Straight Pressure Transducer (DSPT) i...
Surgical Devices·20 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Transpac¿ IV Monitoring Kit, 60", 03 ml Squeeze Flush Device, 2 3 Way Stopcocks and Macrodrip, Item No. 46112-10 The Transpac Disposable...
Surgical Devices·2,640 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
ADD-ON DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP., Item No. 46086-21 The Transpac Disposable Straight Pressure Transdu...
Surgical Devices·660 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Transpac¿ IV Monitoring Kit w/03 ml Squeeze Flush Device, Arterial Safeset" Reservoir and Needleless Valves, Item No. 46112-03 The Trans...
Surgical Devices·275 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRIPLE KIT W/SAFESET" AND 03ML FLUSH DEVICE FOR O.H.S.U., Item No. 46080-38 The Transpac Disposable Straight Pressure Transducer (DSPT) ...
Surgical Devices·160 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK WITHOUT COVERS, Item No. 42663-01NS The Transpac Disposable S...
Surgical Devices·710 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRO...
Surgical Devices·280 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV BIFURCATED MONITORING KIT, 72" 2 DISPOSABLE TRANSDUCERS, with 2 STOPCOCKS, 2 3 ml SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Ite...
Surgical Devices·260 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
LEFT HEART KIT, Item No. AG8052-NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer t...
Cardiac Devices·80 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-21 The Transpac Disposable Straight Pressure Transducer (DSPT) i...
Surgical Devices·130 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV TRIFURCATED MONITORING KIT, 84" 3 DISPOSABLE TRANSDUCERS WITH 2 STOPCOCKS 3 3 ML SQUEEZE FLUSHES, MACRODRIP (POLE MOUNT), It...
Surgical Devices·730 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRANSPAC¿ IV DISPOSABLE TRANSDUCER MONITORING KIT WITH BONDED STOPCOCK AND 3mL SQUEEZE FLUSH, Item No. 42582-09 The Transpac Disposable...
Surgical Devices·520 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
TRIPLE ANESTHESIA KIT W/03ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46064-54 The Transpac Disposable Straight Pressure Transducer...
Surgical Devices·130 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
CATH LAB KIT w/3 PORT "OFF" MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEEDLE & TP-4, Item No. 46098The Transpac Disposable Straight P...
Surgical Devices·105 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Tego Connector, Item No. D1000, NM1000 The Tego¿ Needle Free Access Device is intended for use as an accessory to a vascular access de...
Surgical Devices·476,600 affected·Aug 24, 2016
High RiskFDA
Icu Medical, Inc.
Monitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT)...
Surgical Devices·10 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves, Item No. 011-4...
Surgical Devices·420 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46103-22 Usage: The Transpac Disposable Straight Pressu...
Surgical Devices·20 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, Disposable Transducer, 3 ML Intraflo Flush, Macrodrip (Pole M...
Surgical Devices·60 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24" Tubing, Disposable Transducer, 03 mL Squeeze Flush, Macrod...
Surgical Devices·980 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) ...
Surgical Devices·70 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports, 84 inch Tubing, 3 3 ml Intraflo Flushes, 3 Disposable Tran...
Surgical Devices·250 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) ...
Surgical Devices·20 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
SafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) i...
Surgical Devices·125 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an ex...
Surgical Devices·10 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Needleless Valve, Item No. 46112-65 Product Usa...
Surgical Devices·20 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing, Reservoir, 03 mL Squeeze Flush and 2 Needleless Valves, Item No. ...
Surgical Devices·1,420 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 42500-66 Usage: The Transpac...
Surgical Devices·10 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Monitoring Kit with 03 ml Squeeze Flush, SafeSet Reservoir, 2 Needleless Valves, Mounts and Bracket, Item Nos. 46107-35, 4611...
Surgical Devices·70 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valves, Item No. 42650-66 Prod...
Surgical Devices·90 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75 Product Usage: The Transpac Disposable Straight Pressure Transduce...
Surgical Devices·20 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservoir, Squeeze Flush and Needleless Valve, Item No. 46104-53 ...
Surgical Devices·100 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Triple Line SafeSet Kit with 03mL Flush Device, Item No. 46076-27 Product Usage: The Transpac Disposable Straight Pressure Transduc...
Surgical Devices·150 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, 84", 3.3mL Squeeze Flushes, 3 Disposable Transd...
Surgical Devices·760 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 ml Squeeze Flush Devices, Item No. 46110-84 Usage: The ...
Surgical Devices·150 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Transpac IV Monitoring Kit with 2 SafeSet Reservoir and 2 Blood Sampling Ports, 84" Tubing, Disposable Transducer, 3 mL Squeeze Flush, Ma...
Surgical Devices·4,180 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Single Monitoring Kit with 30mL Flush Device, Item No. 46073-38 Product Usage: The Transpac Disposable Straight Pressure Transducer...
Surgical Devices·20 affected·Aug 10, 2016
High RiskFDA
Icu Medical, Inc.
Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Diana is an automated compounding device for the accurate, safe...
Medical Devices·36 affected·Mar 8, 2016
High RiskFDA
Icu Medical, Inc.
Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000, CH5000R The Diana is an automated compounding devi...
Medical Devices·47 affected·Mar 8, 2016
High RiskFDA
Icu Medical, Inc.
Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 The Diana is an automated compounding device for the accurate, ...
Medical Devices·3 affected·Mar 8, 2016
High RiskFDA
Icu Medical, Inc.
30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros, Hanger, Drop-In Red Cap, Item No. CL 3011 Clere...
Medical Devices·19,250 affected·Feb 25, 2016
High RiskFDA
Icu Medical, Inc.
30" (76 cm) Appx. 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. CL3...
Medical Devices·50 affected·Feb 25, 2016
High RiskFDA
Icu Medical, Inc.
30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Hanger, Item No. CL3511 st...
Medical Devices·7,500 affected·Feb 25, 2016
High RiskFDA
Icu Medical, Inc.
31" (79 cm) Appx. 3.4 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Spiros, Bag Hanger, Item No. SL3011 sterile device...
Medical Devices·400 affected·Feb 25, 2016
High RiskFDA
Icu Medical, Inc.
110" (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Clave, Rotating Luer, Bag Hanger, Item No. AHCL3...
Medical Devices·350 affected·Feb 25, 2016