Device recall
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
- Recall number
- Z-3263-2026
- Event id
- 99606
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Report date
- Sep 30, 2026
- Posted
- Sep 24, 2026
- Initiated
- Aug 18, 2026
- Center classification date
- Sep 24, 2026
- Product code
- IOQ
- Device type
- Bed, Flotation Therapy, Powered
- Reason
- 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.
- Root cause
- Process control
- Quantity
- 824 units
- Code info
- Serial Number: A136BP2433 - B052BP6510 UDI-DI Number: 00887761007659
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Deerfield, IL, United States