3M Company recalls 3M Ranger Irrigation Fluid Warming Set

Notice was issued to clarify flow rates related to the inlet fluid temperature.

Solventum issued an Urgent Medical Device Correction notice dated 04/21/2025 to its consignees via email and US certified mail. The notice explained the issue, the modification related to the inlet fluid temperature to address the issue, and forthcoming instructions for use updates. All users of the impacted products are being asked to take the following actions. " Ensure this notification is passed on to all those who need to be aware within your organization and to any department where the affected products have been transferred. " Continue to use the products as indicated, considering the updated information provided. " Keep this notice on hand until you are notified that the updated IFUs and operator s manuals are available. " Complete the attached Customer Acknowledgement Form acknowledging that you have read and understood this letter and the updated information provided. " Email the completed form to 3MFieldSafetyAction@montage72.com. For additional questions or need to report an adverse event, contact the Solventum [formerly 3M Health Care] Customer Helpline at 1-800-228-3957, option 6.

• FDA enforcement recordOfficial FDA database entry for Z-2231-2025
• FDA 510(k) clearance · K060939The device's official FDA premarket clearance record
• FDA device classification · LGZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5725The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find 3M CompanySearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.