pro+ recallZ-3264-2026 · Baxter Healthcare Corporation · initiated Aug 18, 2026

Why it was recalled

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 category: Process control

What the company is doing

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.

Recall details

Recall number

Z-3264-2026

Status

Open, Classified

Initiated by the company

Aug 18, 2026

Posted by the FDA

Sep 24, 2026

Recalling firm

Baxter Healthcare Corporation

Quantity

6 units

Product code

IOQ

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Product description

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• pro+ P7924A14

  Hill-Rom, Inc. · Bed, Flotation Therapy, Powered
  1 recall0 reports

Product lines

• pro+Hill-Rom, Inc. · 18 models · 36 reports · 13 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 99606).

• Z-3262-2026 · Open, Classified
  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 redistri…
• Z-3263-2026 · Open, Classified
  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 whe…