HIGHFDA DEVICE

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...

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.

ICU MedicalHealth & Personal CareMedical DevicesUDI-DI: 30695085407007Lot Numbers: 42935684293569

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
June 24, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
June 24, 2026
Hazard Level
HIGH
Brand
ICU Medical
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
ICU Medical
Model numbers
UDI-DI: 30695085407007, Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725 +1 more
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    June 24, 2026

  2. Reported by FDA DEVICE

    July 29, 2026

  3. RecallRadar source check

    August 4, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ICU Medical Inc. or your healthcare provider for instructions. Notification method: Letter

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Full 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: 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.. Classification: Class II. Quantity: 39,750 units. Distribution: Worldwide - US Nationwide distribution.

Safety Guide

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Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
UDI-DI: 30695085407007
Lot Numbers: 4293568
4293569
4297510
4297509
+4 more
Affected States
ALL
Report Date
July 29, 2026
Recall Status
ACTIVE

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