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
December 30, 2020FDA26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795Z-0711-2021
December 30, 2020FDA30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/…Z-0703-2021
October 28, 2020FDA5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 pouches per c…Z-0185-2021
October 28, 2020FDA7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave T-Connector…Z-0187-2021
October 28, 2020FDAAPPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings)BCV. 1 unit…Z-0272-2021
October 28, 2020FDA7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating…Z-0186-2021
October 28, 2020FDA6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Rotating Luer;…Z-0183-2021
October 28, 2020FDA7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouc…Z-0247-2021
October 28, 2020FDA112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-W…Z-0258-2021
October 28, 2020FDA226 cm (89 IN) APPX 2.7ml, MicroClave Clear, 1.2v FILTER Nanoclave T-CONN. 1 unit per po…Z-0275-2021
October 28, 2020FDADISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green R…Z-0271-2021
October 28, 2020FDA83" (211 cm) Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave¿ Stopcock w/Baseplate, Rotat…Z-0221-2021
October 28, 2020FDAClave Stopcock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709039916(…Z-0250-2021
October 28, 2020FDA126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang 4-Way NanoCl…Z-0218-2021
October 28, 2020FDA9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating Luer;1 uni…Z-0209-2021
October 28, 2020FDA11 IN (28cm) APPX 1.5ml EXT SET NanoClave, 6-Port NanoClave Manifold . 1 unit per pouch, …Z-0242-2021
October 28, 2020FDA10 IN (25cm) APPX 1.1ml, SMALLBORE EXT w/3-Port NanoClave Manifold, Check Valve. 1 unit p…Z-0279-2021
October 28, 2020FDAAppx 0.82 ml, 3 Gang 4-Way NanoClave¿ Stopcock Manifold w/Rotating Luer. 1 unit per pouch…Z-0220-2021
October 28, 2020FDA6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClav…Z-0193-2021
October 28, 2020FDA13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave Clear. 1 unit…Z-0210-2021
October 28, 2020FDA26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit…Z-0223-2021
October 28, 2020FDA114" (290 cm) 60 Drop 150ml Burette Set (Clave, Shut Off, Filter) w/4 Clave Remv 3-Port N…Z-0230-2021
October 28, 2020FDA13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn, Filter; 1 u…Z-0207-2021
October 28, 2020FDA6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroCla…Z-0204-2021
May 27, 2020FDALACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake…D-1270-2020

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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