CLASS II ONGOING Device recall · Reported 6 Aug 2025 · FDA Enforcement Report
3M Ranger Irrigation Fluid Warming Set recalled
3M is recalling 3M Ranger Irrigation Fluid Warming Set, distributed nationwide in the US. The recall was initiated on 22 Apr 2025 and the FDA has classified it as Class II.
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-2231-2025
- FDA event ID
- 97174
- Recalling firm
- 3M, Saint Paul, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Apr 2025
- FDA classified
- 31 Jul 2025
- Reported
- 6 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Temperature Abuse
- Device type
- Other Medical Devices
Timeline
| 22 Apr 2025 | Recall initiated by company | |
| 31 Jul 2025 | Classified by FDA | +100 days |
| 6 Aug 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
Notice was issued to clarify flow rates related to the inlet fluid temperature.
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 Irrigation Fluid Warming Set, REF 24750
Where it was distributed
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.
Questions about this recall
Is 3M Ranger Irrigation Fluid Warming Set recalled?
Yes. 3M recalled 3M Ranger Irrigation Fluid Warming Set on 22 Apr 2025. The recall is Class II and its status is Ongoing. Recall number Z-2231-2025.
Why was it recalled?
Notice was issued to clarify flow rates related to the inlet fluid temperature.
Which lots are affected?
UDI/DI 50707387792720 (box), 10707387792722 (pouch, )SKU 7100235070, All lots with a manufacturing date after March 2022
Where was it sold?
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.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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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