FDA-Device2026-09-30Class IIMISBRANDING

Baxter Healthcare PRO+ 36" MRS SURFACE mattress recalled for incorrect UDI labeling

LABEL MIX UPNationwide distributionMedical devices

What this means

Baxter Healthcare's PRO+ 36" MRS SURFACE mattress has an error in the product description on its Unique Device Identification (UDI) label. This mislabeling could cause the mattress to be confused with other products or used with an incompatible bed frame.

  • Check the UDI label on your mattress for the affected serial numbers (A136BP2433 to B052BP6510).
  • Do not use the mattress with a bed frame unless you confirm compatibility with Baxter Healthcare or your distributor.
  • Contact Baxter Healthcare or your supplier for clarification or a replacement.
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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
824 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3263-2026

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