Recall Record

Saint Paul, MN, United States

3M Company recalls

2 recalls recorded since 2018, most recently on 22 April 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.

Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)1

Ongoing Class II Medical devices

Recall started
22 April 2025
Reason
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, Luxe
Initiated
Voluntary: Firm initiated
Recall number
Z-2231-2025

Ongoing Class I Medical devices

Recall started
10 April 2025
Reason
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.
Distribution
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,
Initiated
Voluntary: Firm initiated
Recall number
Z-2483-2025

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.