ICU Medical Inc. Hotline Fluid Warming Set, single use device recall: ICU Medical became aware of an increased likelihood of leakage in specific
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.
The hazard: Device safety concern
The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
What the notice says: 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.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-2759-2026
- Published
- July 29, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- ICU Medical Inc.
- Product type
- Medical devices
- Units affected
- 39,750 units
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- UDI-DI: 30695085407007; Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349
- UPC codes
- 30695085407007
Products covered by this recall
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
Check your product
The notice names 9 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 30695085407007
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- 4293568
- 4293569
- 4297510
- 4297509
- 4326087
- 4337724
- 4337725
- 4346349
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
ICU Medical Inc. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- Ask the supplier or clinic that provided it what the remedy is in your case.
- If you are a facility, quarantine affected stock and log the correction.
- Report device problems to the FDA through MedWatch.
Who pays for a device recall
The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.
- If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
- Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
- If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
- Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.
Company contact: ICU Medical Inc. — 6000 Nathan Ln N, Minneapolis, MN, 55442-1690
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was ICU Medical Inc. medical devices recalled?
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 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.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 30695085407007; lot code 4293568, 4293569, 4297510. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
Where was the recalled product sold?
It was distributed nationwide.
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