Z-3263-2026 Class II Ongoing
FDA device recall Z-3263-2026 was initiated by Baxter Healthcare Corporation on Aug 18, 2026 and is designated Class II. Reason for recall: There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may l… The recall status is ongoing. Affected quantity: 824 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 30, 2026
- Initiation Date
- Aug 18, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 824 units
Product Description
PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned, Model/Catalog Number: P7924A13
Reason for Recall
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
Serial Number: A136BP2433 - B052BP6510 UDI-DI Number: 00887761007659