Level 1 recallZ-2759-2026 · ICU Medical Inc. · initiated Jun 24, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ICU Medical Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process control
What the company is doing
An URGENT: MEDICAL DEVICE CORRECTION notification letter dated 6/24/26 was sent to customers. Actions for Users: When using the device, all instructions, including warnings and cautions contained in the Instructions for Use must be followed with heightened awareness. Please complete the following actions below. 1. Locate potentially affected devices from the Lots listed in Table 1 above. 2. Destroy all affected products following your institution s process for destruction. If destroying is not immediately possible at your facility, then the product should be quarantined until disposal. 3. Share this notification with all potential users of the device to ensure they are aware of this notification. If the devices are used at another location, please ensure that this communication is delivered there. 4. Complete and return the attached Customer Response Form to [email protected] within 10 days of receipt to acknowledge your understanding of this notification. Required Actions for Distributors: When using the device, all instructions, including warnings and cautions contained in the Instructions for Use must be followed with heightened awareness. Please complete the following actions below. 1. Locate potentially affected devices from the Lots listed in Table 1 above. 2. Destroy all affected products following your institution s process for destruction. If destroying is not immediately possible at your facility, then the product should be quarantined until disposal. 3. Share this notification with all potential users of the device to ensure they are aware of this notification. If the devices are used at another location, please ensure that this communication is delivered there. 4. Complete and return the attached Customer Response Form to [email protected] within 10 days of receipt to acknowledge your understanding of this notification. 5. DISTRIBUTORS: Immediately forward this notice to all users to whom you distributed these products. IC
Recall details
- Recall number
- Z-2759-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 24, 2026
- Posted by the FDA
- Jul 17, 2026
- Recalling firm
- ICU Medical Inc.
- Quantity
- 39,750 units
- Product code
- LGZ
- FDA submissions
- K911383
- Distribution
- Worldwide - US Nationwide distribution.
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
Code information (models, lots, serial numbers)
UDI-DI: 30695085407007; Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Level 1 L-70Icu Medical, Inc. · Warmer, thermal, infusion fluid1 recall385 reports
Product lines
Other devices under the same FDA submission
9 devices cleared under K911383 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Level 1 HL-90Icu Medical, Inc. · Warmer, thermal, infusion fluid991 reports
- Level 1 HL-390Icu Medical, Inc. · Warmer, thermal, infusion fluid634 reports
- Level 1 L-70NIIcu Medical, Inc. · Warmer, thermal, infusion fluid114 reports
- Level 1 L-10Icu Medical, Inc. · Warmer, thermal, infusion fluid41 reports
- Level 1 L-370Icu Medical, Inc. · Warmer, thermal, infusion fluid24 reports
- Level 1 HL-390-38Icu Medical, Inc. · Warmer, thermal, infusion fluid9 reports
- Level 1 HL-90-38Icu Medical, Inc. · Warmer, thermal, infusion fluid5 reports
- Level 1 HL-390-40Icu Medical, Inc. · Warmer, thermal, infusion fluid3 reports
- Level 1 HL-90-40Icu Medical, Inc. · Warmer, thermal, infusion fluid2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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