Class 2 Device Recall PRO 36" MRS SURFACE

• Date Initiated by Firm: August 18, 2026
• Date Posted: September 24, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3263-2026
• Recall Event ID: 99606
• Product Classification: Bed, flotation therapy, powered - Product Code IOQ
• Product: 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
• Code Information: Serial Number: A136BP2433 - B052BP6510 UDI-DI Number: 00887761007659
• FEI Number: 1417572
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 1-847-9484770
• Manufacturer 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 Determined 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: 824 units
• Distribution: Worldwide distribution - US Nationwide and the country of Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.