3M Ranger recallZ-2231-2025 · 3M Company · initiated Apr 22, 2025
Class II Open, Classified All recalls posted in August 2025
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 3M Company 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
Notice was issued to clarify flow rates related to the inlet fluid temperature.
FDA root cause category: Device Design
What the company is doing
Solventum issued an Urgent Medical Device Correction notice dated 04/21/2025 to its consignees via email and US certified mail. The notice explained the issue, the modification related to the inlet fluid temperature to address the issue, and forthcoming instructions for use updates. All users of the impacted products are being asked to take the following actions. " Ensure this notification is passed on to all those who need to be aware within your organization and to any department where the affected products have been transferred. " Continue to use the products as indicated, considering the updated information provided. " Keep this notice on hand until you are notified that the updated IFUs and operator s manuals are available. " Complete the attached Customer Acknowledgement Form acknowledging that you have read and understood this letter and the updated information provided. " Email the completed form to [email protected]. For additional questions or need to report an adverse event, contact the Solventum [formerly 3M Health Care] Customer Helpline at 1-800-228-3957, option 6.
Recall details
- Recall number
- Z-2231-2025
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Apr 22, 2025
- Posted by the FDA
- Aug 1, 2025
- Recalling firm
- 3M Company
- Quantity
- 186,880 units
- Product code
- LGZ
- FDA submissions
- K060939
- Distribution
- US (nationwide) and Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, Canary Islands, China, Costa Rica, Croatia, Czech Republic, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Korea, Luxembourg, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam.
Product description
3M Ranger Irrigation Fluid Warming Set, REF 24750
Code information (models, lots, serial numbers)
UDI/DI 50707387792720 (box), 10707387792722 (pouch, )SKU 7100235070, All lots with a manufacturing date after March 2022
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- 3M™ Ranger™ 247503m Company · Warmer, thermal, infusion fluid1 recall0 reports
Product lines
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 18, 2026. Text above is shown as published by the FDA.
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