CLASS I ONGOING Device recall · Reported 24 Sep 2025 · FDA Enforcement Report
3M Ranger Blood/Fluid Warming High Flow Set recalled
3M is recalling 3M Ranger Blood/Fluid Warming High Flow Set, distributed nationwide in the US. The recall was initiated on 10 Apr 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2483-2025
- FDA event ID
- 96841
- Recalling firm
- 3M, Saint Paul, MN
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 10 Apr 2025
- FDA classified
- 18 Sep 2025
- Reported
- 24 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Other Medical Devices
Timeline
| 10 Apr 2025 | Recall initiated by company | |
| 18 Sep 2025 | Classified by FDA | +161 days |
| 24 Sep 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
Where it was distributed
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.
Questions about this recall
Is 3M Ranger Blood/Fluid Warming High Flow Set recalled?
Yes. 3M recalled 3M Ranger Blood/Fluid Warming High Flow Set on 10 Apr 2025. The recall is Class I and its status is Ongoing. Recall number Z-2483-2025.
Why was it recalled?
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.
Which lots are affected?
All lots with a manufacturing date after March 2022.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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