Summary
The FDA issued a Class I for 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370 by 3M Company. Reason: Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet temperature for Ranger Blood/Fluid Warming High.
Details
Source
Device Recall
External ID
Z-2483-2025
Action Date
2025-09-24
Status
Ongoing
Category
device
Product Description
3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
Lot/Code Info: All lots with a manufacturing date after March 2022.
Quantity Affected: 530,470 units
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.
Distribution
Worldwide 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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-10
Company
Saint Paul, MN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 133 device recalls issued in the same week, part of 403 device-related FDA actions this month.
3M Company has 17 FDA actions in our database, including 2 recalls and 15 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (3M Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does 3M Company have FDA actions?
3M Company has 17 FDA actions in our database, including 2 recalls and 15 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2483-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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