FDA Devices recall · Reported July 29, 2026
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
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 …
Icu Medical Inc. recalled Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous f… - a moderate-severity action.
Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous f… was recalled by Icu Medical Inc. in July 29, 2026. Reason: ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming…. Check the official notice for the remedy. Verify recall #Z-2759-2026 with the FDA Devices before acting.
The recall
Icu Medical Inc. issued this moderate-severity FDA Devices recall-ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming….
- Moderate
- severity level
- 40K units
- affected scope
- Class II
- classification
- July 29, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2759-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2759-2026) was formally reported on July 29, 2026, with the manufacturer initiating the action on June 24, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Icu Medical Inc. is listed as the recalling firm, operating out of Minneapolis, MN. Federal records list the affected scope as 39,750 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide - US Nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2759-2026 |
| Date reported | July 29, 2026 |
| Date initiated | June 24, 2026 |
| Recalling firm | Icu Medical Inc. |
| Firm location | Minneapolis, MN |
| Affected scope | 39,750 units |
| Distribution | Worldwide - US Nationwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2759-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
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Methodology · Corrections · Archive as of August 2026