Recall StatusOpen, Classified
Date Initiated2025-04-22
Product Quantity186,880 units
Reason for Recall
Notice was issued to clarify flow rates related to the inlet fluid temperature.
Firm Action
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
[email protected].
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.
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.