Notice names this product. ICU Medical’s Hotline Fluid Warming Set is named in FDA Class II recall Z-2759-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond. Identifying details: UDI-DI: 30695085407007; Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349. Units affected: 39,750 units. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions, List Number L-70
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing t…
Company / brand: ICU Medical
Affected product: Hotline Fluid Warming Set
Official ID Z-2759-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.