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U.S. Department of Health and Human Services

Class 1 Device Recall 3M Ranger

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 Class 1 Device Recall 3M Rangersee related information
Date Initiated by FirmApril 10, 2025
Date PostedSeptember 18, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2483-2025
Recall Event ID 96841
510(K)NumberK973741 
Product Classification Warmer, blood, non-electromagnetic radiation - Product Code BSB
Product3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
Code Information All lots with a manufacturing date after March 2022.
Recalling Firm/
Manufacturer		 3M Company
2510 Conway Ave E
3m Center, Building 275-5w-06
Saint Paul MN 55144-0001
For Additional Information ContactAshish Patel
619-854-1240
Manufacturer Reason
for Recall		Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet temperature for Ranger Blood/Fluid Warming High Flow Sets.
FDA Determined
Cause 2		Device Design
ActionAn Urgent Medical Device Correction letter was sent to all their customers on 4/21/2025 to inform them that Solventum [formerly 3M Company] clarified flow rates related to the inlet fluid temperature. The device instructions for use (IFU) will be updated to reflect these changes. Customers are informed that there have been no changes to the design or composition of these products that prompted this notification. Customers are instructed to continue to use the products as indicated, considering the updated information provided in the letter. If the device is used at a flow rate outside of the updated information provided, there is a potential risk for the device to administer the fluids at a lower temperature than indicated and cause a decrease in patient temperature. Under the dire circumstances of a massive rapid infusion where high flow rates outside of the updated ranges indicated below may be used, there is a potential for hypothermia. Customers with additional questions or need to report an adverse event, are instructed to contact the Solventum [formerly 3M Health Care] Customer Helpline at 1-800-228-3957, option 6.
Quantity in Commerce530,470 units
DistributionWorldwide distribution. US nationwide including Puerto Rico, Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, Canary Islands, China, Costa Rica, Croatia, Czechia, 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, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, UAE, UK, and Vietnam.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BSB
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