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
June 27, 2018FDA5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC…D-0885-2018
April 18, 2018FDA6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, R…Z-1342-2018
November 29, 2017FDASURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin S…Z-0106-2018
August 23, 2017FDA0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira, I…D-1091-2017
July 19, 2017FDA10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rin…Z-2724-2017
July 19, 2017FDA28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 NanoClave¿, R…Z-2718-2017
July 19, 2017FDA10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotating Luer. …Z-2723-2017
July 19, 2017FDA168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check V…Z-2717-2017
January 18, 2017FDA133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating Luer, 1 Ext…Z-0980-2017
January 18, 2017FDATego Connector, Item No. D1000, NM1000 The Tego¿ Needle Free Access Device is intended…Z-0988-2017
November 23, 2016FDACATH LAB KIT w/4 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE, WASTE BASIN, SHARPSTOP & TP4, It…Z-0531-2017
November 23, 2016FDATRANSPAC¿ IV MONITORING KIT, 9", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MACRODRIP (…Z-0433-2017
November 23, 2016FDAMONITORING KIT W/30 ML FLUSH DEVICE FOR EGLESTON HOSP., Item No. 46094-50 The Transpac D…Z-0514-2017
November 23, 2016FDASINGLE A LINE KIT CC5 W/03ML FLUSH DEVICE FOR ALBERT EINSTEIN M.C., Item No. 46047-17 Th…Z-0456-2017
November 23, 2016FDAMonitoring Kit #3 w/03 ml Flush Device for Childrens Hosp, Item No. 46010-34 The Transpa…Z-0455-2017
November 23, 2016FDATranspac¿ IV Trifurcated Monitoring Kit 84" w/03 ml Squeeze Flush Device, Red, Blue and Y…Z-0566-2017
November 23, 2016FDAPEDIATRIC ARTERIAL KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 46065-65 T…Z-0470-2017
November 23, 2016FDATRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 84" TUBING, …Z-0447-2017
November 23, 2016FDACATH LAB KIT FOR SALINA REGIONAL, Item No. 46092-34 The Transpac Disposable Straight Pre…Z-0507-2017
November 23, 2016FDA2 PORT RIGHT "OFF" MANIFOLD w/ADMIN SET 72" PT, 3 WAY STOPCOCK, TP4 & 1 WAY STOPCOCK, Ite…Z-0533-2017
November 23, 2016FDACATH LAB KIT w/3 PORT ''ON'' MANIFOLD, WASTE BAG, TP4, SYRINGES & 30 ml BURETTE, Item No.…Z-0520-2017
November 23, 2016FDATRANSPAC¿ IV MONITORING KIT NEONATAL, 24", DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH (IN…Z-0430-2017
November 23, 2016FDAMonitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46104-07 The Tr…Z-0548-2017
November 23, 2016FDATranspac¿ IV Bifurcated Monitoring Kit w/03 ml Squeeze Flush Device, PT Tubings, 3-Way St…Z-0569-2017
November 23, 2016FDAARTERIAL SET-UP W/03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., Item No. 46068-49 The Tr…Z-0475-2017

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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