Z-3262-2026Class II

PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered...

Name: Z-3262-2026 PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered...
Creator: Baxter Healthcare Corporation
Published: 2026-08-18
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2026-08-18 / Open, Classified

FDA source

Recall record

Recall number: Z-3262-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-18
Posted: 2026-09-24
Recalling firm: Baxter Healthcare Corporation
Product: 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
Product code: IOQ Bed, Flotation Therapy, Powered
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.
FDA root cause: Process control
Action: An "Urgent Medical Device Correction notification" letter dated 8/18/26 was sent to customers. Actions to be Taken by Customers 1.Locate the affected product at your facility and confirm each Product Code. Once product has been identified, use Hillrom pro+ Surface Instructions for Use (209196) (IFU) to assess the fit of the surfaces relative to the frame and siderails to confirm the surface is installed properly. If the surface does not meet the requirements set in the IFU please discontinue the use of this surface. 2. A Baxter representative will contact your facility to replace the incorrect label when it becomes available. 3. If you received this communication directly from Baxter, please acknowledge receipt of this notification by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com even if you do not have any remaining inventory. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from Accenture LLP on behalf of Baxter to confirm your receipt of this notification. 4. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to the supplier according to their instructions. 5. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction. For general questions regarding this communication, please contact Baxter Global Technical Service at 800-445-3720 Option 2 between 8:00 am and 6:00 pm Eastern Time Monday through Friday.
Quantity in commerce: 169 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: Serial Number: A171BP3769 - B057BP6765 UDI-DI Number: 00887761007543

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3262-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3262-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-24
Z-3263-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-24
Z-3264-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-24

Product code IOQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-29. View this recall on fda.gov (opens on fda.gov)