PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and outpu
Summary
The FDA issued a Class II for PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses by 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 ap.
Details
Source
Device Recall
External ID
Z-3263-2026
Action Date
2026-09-30
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Serial Number: A136BP2433 - B052BP6510 UDI-DI Number: 00887761007659
Quantity Affected: 824 units
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-18
Company
Deerfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 196 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Baxter Healthcare Corporation has 335 FDA actions in our database, including 311 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 335 FDA actions in our database, including 311 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3263-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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