OVERLOOKED

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Class IIOngoing

Baxter Healthcare Corporation recalls 3 products

Recall date · record updated Sep 30, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Baxter Healthcare Corporation
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.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Worldwide distribution - US Nationwide and the country of Canada.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99606…

Products (3)

  1. 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

    Codes/lots: Serial Number: A171BP3769 - B057BP6765 UDI-DI Number: 00887761007543Quantity: 169 unitsRecall no. Z-3262-2026Class II

  2. 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

    Codes/lots: Serial Number: A136BP2433 - B052BP6510 UDI-DI Number: 00887761007659Quantity: 824 unitsRecall no. Z-3263-2026Class II

  3. 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

    Codes/lots: Serial Number: A305BP8842 - A305BP8847 UDI-DI Number: 00887761007666Quantity: 6 unitsRecall no. Z-3264-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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