Recall archive
7 recalls · page 1 of 1
Reported Jul 29, 2026
Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical Inc.
Matched: Brand · Reason for recall — ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate…
FDA (openFDA device enforcement)
Reported Jan 21, 2026
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical Inc.
Matched: Brand — Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical Inc.
Matched: Brand · Product · Product details — Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 18, 2017
133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating Luer, 1 Ext, Item No. B59006 Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand · Reason for recall — ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a device which should contain a 60 drop drip chamber.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 23, 2016
4 Port "ON" Manifold (600 psi) w/4 ft. Transpac¿ IV, Item No. 46300-14NS The Transpac Disposable Straight Pressure…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand · Reason for recall — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
161 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 21, 2016
Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand · Reason for recall — ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
23 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 20, 2016
Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Diana is an automated compounding device for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ICU Medical, Inc.
Matched: Brand · Reason for recall — ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing…
5 more products in this recall
FDA (openFDA device enforcement)
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