Recall Z-3263-2026— Baxter Healthcare Corporation
Class II · Ongoing
Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2026-08-18. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-18
- Firm location
- Deerfield, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.