ICU Medical Hotline Fluid Warming Set Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
ICU Medical Inc. is recalling 39,750 units of its Hotline Fluid Warming Set due to potential leakage from inadequate solvent application at the tubing to return connector bond.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 12, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Medical Devices.
What Happened
ICU Medical Inc. initiated a voluntary recall after becoming aware of an increased likelihood of leakage in specific lots of the L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.
Which Products Are Affected
The recall affects the Hotline Fluid Warming Set, single use device, List Number L-70, designed to warm blood and intravenous fluids. Affected lot numbers are: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349. UDI-DI is 30695085407007. A total of 39,750 units were distributed nationwide in the US and worldwide.
What You Should Do
Consumers should contact ICU Medical Inc. regarding the recalled devices.
Why This Matters
This Class II recall involves a device distributed across the United States with a risk of leakage that could affect fluid delivery.
Source
FDA recall number Z-2759-2026, event ID 99289.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (943 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 12, 2026.
Frequently Asked Questions
Common questions about this FDA recall.