Summary
The FDA issued a Class II for 3M Ranger Irrigation Fluid Warming Set, REF 24750 by 3M Company. Reason: Notice was issued to clarify flow rates related to the inlet fluid temperature..
Details
Source
Device Recall
External ID
Z-2231-2025
Action Date
2025-08-06
Status
Ongoing
Category
device
Product Description
3M Ranger Irrigation Fluid Warming Set, REF 24750
Lot/Code Info: UDI/DI 50707387792720 (box), 10707387792722 (pouch, )SKU 7100235070, All lots with a manufacturing date after March 2022
Quantity Affected: 186,880 units
Reason for Recall
Notice was issued to clarify flow rates related to the inlet fluid temperature.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-22
Company
Saint Paul, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 157 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 II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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-2231-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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