FDA Device recall Z-3262-2026
PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves…
- FDA Device
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves… by Baxter Healthcare, citing 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 spe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3262-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-18 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
PRO+ MRS SURFACE FOR VERSACARE, 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: P3255A08
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.
Identifiers
| code_info | Serial Number: A171BP3769 - B057BP6765 UDI-DI Number: 00887761007543 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
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FDA Drug · Class II · 2026-09-09 · Baxter Healthcare
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3262-2026%22
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