Hotline Fluid Warming Set — Class II medical device recall Z-2759-2026
Ongoing recall by ICU Medical Inc., reported 2026-07-29, distributed nationwide. ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming
| Recall number | Z-2759-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical Inc., Minneapolis, MN, United States |
| Recall initiated | 2026-06-24 |
| Classified | 2026-07-17 |
| Reported by FDA | 2026-07-29 |
| Distributed | Nationwide (US) |
| Quantity | 39,750 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 30695085407007 |
| Lot numbers | 4293568, 4293569, 4297509, 4297510, 4326087, 4337724, 4337725, 4346349 |
Product
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
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 solvent application at the tubing to return connector bond.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2759-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.