FDA-Device2026-09-30Class IIMISBRANDING

Baxter PRO+ MRS SURFACE FOR VERSACARE mattress recalled for labeling error affecting bed frame compatibility

LABEL MIX UPNationwide distributionMedical devices

What this means

The Baxter PRO+ MRS SURFACE FOR VERSACARE mattress has an error in the product description on its UDI (Unique Device Identification) label. This labeling discrepancy may cause the product to be incorrectly identified or selected, which could result in the mattress being used with an incompatible bed frame.

  • Check the UDI label on your Baxter PRO+ MRS mattress (Model P3255A08, serial numbers A171BP3769 through B057BP6765).
  • Verify the product description on the label matches your bed frame specifications.
  • Contact Baxter Healthcare Corporation or your medical equipment supplier if you have questions about compatibility.
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The agency's original wording
Hazard

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.

Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
169 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3262-2026

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