FDA Device recall Z-3264-2026
PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide…
- FDA Device
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide… 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-3264-2026 |
| 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+ 40" 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: P7924A14
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: A305BP8842 - A305BP8847 UDI-DI Number: 00887761007666 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
Other recalls by Baxter Healthcare
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FDA Device · Class II · 2026-09-30 · Baxter Healthcare - Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, H…
FDA Device · Class II · 2026-09-30 · Baxter Healthcare - PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves…
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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-3264-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.