ICU Medical, Inc.: 242 recalls on record

Recalls filed with 1 agency: FDA (242).

First recall on record: August 8, 2012. Most recent: September 23, 2026.

Risk classification: Class I: 15 · Class II: 227

Most recent recalls

DateAgencyProduct
November 23, 2016FDATRANSDUCER KIT FOR MEDICAL CTR. AT BOWLING GREEN, Item No. 46097-64 The Transpac Disposa…Z-0525-2017
November 23, 2016FDARight Heart Cath Lab Kit w/2 Port "OFF" Manifold (600 psi), 72" Spike Set, Transpac¿ IV a…Z-0541-2017
November 23, 2016FDATRANSPAC¿ IV TRIFURCATED MONITORING KIT 60 INCH, 3 DISPOSABLE TRANSDUCERS, 3 3 ML SQUEEZE…Z-0434-2017
November 23, 2016FDATranspac¿ IV Trifurcated Monitoring Kit w/03 ml Squeeze Flush Device, Arterial Safeset" R…Z-0560-2017
November 23, 2016FDACardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressure Manifo…Z-0491-2017
November 23, 2016FDACATH LAB KIT W/3 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE & TP4, Item No. AG7891-NS The Tr…Z-0574-2017
September 21, 2016FDATranspac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squee…Z-2805-2016
September 21, 2016FDAMonitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: The Transpa…Z-2815-2016
September 21, 2016FDAMonitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Need…Z-2828-2016
September 21, 2016FDA5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: The Transpac Disposa…Z-2822-2016
September 21, 2016FDATranspac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, Disposable Tr…Z-2808-2016
September 21, 2016FDAMonitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46103-22 …Z-2823-2016
September 21, 2016FDATranspac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing, Reservoir, 03 mL …Z-2810-2016
September 21, 2016FDASafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: The Transpac …Z-2819-2016
September 21, 2016FDAPediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: The Transpac…Z-2821-2016
April 20, 2016FDADiana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Diana is an aut…Z-1364-2016
April 6, 2016FDA30" (76 cm) Appx. 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.…Z-1260-2016
April 6, 2016FDA30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros,…Z-1258-2016
April 6, 2016FDA30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Dri…Z-1259-2016
May 13, 2015FDA107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non…Z-1589-2015
May 13, 2015FDA98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock, Non-DEHP T…Z-1595-2015
October 1, 2014FDA83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave…Z-2621-2014
October 1, 2014FDASTAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2…Z-2620-2014
October 1, 2014FDASTAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2…Z-2619-2014
October 1, 2014FDA98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, R…Z-2622-2014

Questions about this company

How many recalls does ICU Medical, Inc. have?
Recalert has 242 U.S. recalls on record for ICU Medical, Inc., published between August 8, 2012 and September 23, 2026.
Which agencies have handled ICU Medical, Inc. recalls?
ICU Medical, Inc. appears as the recalling firm in recalls from: FDA (242).

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