Z-2231-2025 Class II Ongoing
FDA device recall Z-2231-2025 was initiated by 3M Company on April 22, 2025 and is designated Class II. Reason for recall: Notice was issued to clarify flow rates related to the inlet fluid temperature. The recall status is ongoing. Affected quantity: 186,880 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 6, 2025
- Initiation Date
- April 22, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 186,880 units
Product Description
Reason for Recall
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.