Class II — Baxter Healthcare Corporation
| Recalling firm | BAXTER HEALTHCARE CORPORATION |
|---|---|
| Registered facility | View this company's 32 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| 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 |
| Quantity | 824 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| Initiated | 2026-08-18 |
| Classified | 2026-09-24 |
| Recall number | Z-3263-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Baxter Healthcare Corporation (Z-3263-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99606/
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