FDA-Device2026-09-30Class IIMISBRANDING

Baxter PRO+ 40" MRS SURFACE mattress recalled for labeling error risk of incompatible bed frame use

LABEL MIX UPNationwide distributionMedical devices

What this means

Baxter Healthcare's PRO+ 40" MRS SURFACE mattress has an error in the product description printed on its UDI (Unique Device Identification) label. This mislabeling may cause healthcare facilities or users to misidentify the product or select an incompatible bed frame, potentially affecting safe use of the mattress.

  • Check the UDI label on your PRO+ 40" MRS SURFACE mattress (Model P7924A14, serial numbers A305BP8842–A305BP8847).
  • Verify the mattress is being used with the correct bed frame model before patient use.
  • Contact Baxter Healthcare if you are unsure whether your unit is affected or need labeling clarification.
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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
All ages
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
6 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3264-2026

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