Class 2 Device Recall Adapt Pump"

• Date Initiated by Firm: January 21, 2026
• Date Posted: February 26, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1472-2026
• Recall Event ID: 98332
• Product Classification: Mattress, air flotation, alternating pressure - Product Code FNM
• Product: Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt Air Pro EX, Adapt Convertible, Adapt Convertible EX), sofware version 1.3.0; Mattress, Air Flotation, Alternating Pressure
• Code Information: UDI-DI 0084569904914; All serial numbers with a manufacturing date prior to 12/04/2025
• FEI Number: 3002693132
• Recalling Firm/ Manufacturer: Agiliti Health - Ellis; 204 W 2nd St; Ellis KS 67637-2026
• For Additional Information Contact: Heidi Drafall; 1-800-8149389
• Manufacturer Reason for Recall: Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support surfaces does not re-engage the Microclimate Management function after using the Autofirm function for 10 minutes. This issue only occurs when the 10-minute timer is allowed to elapse after the Autofirm button is pressed after initial setup, and it only affects the Microclimate Management function.
• FDA Determined Cause: Software design
• Action: The firm issued an URGENT: Medical Device Correction notice to its consignees on 01/21/2026 via email. The notice explained the issue with the device, potential risk, how to recognize the failure, and requested the following: "Actions to be Taken by Customer 1. Immediately share this Notice with all necessary parties within your organization. 2. Examine the stock in your organization to determine if you have any of the devices in your organization. a. If any devices have been transferred to another organization, please forward a copy of this Advisory Notice and the attached Customer Response Form to that organization. 3. Complete the attached Customer Response Form, even if your organization no longer possesses any devices. 4. Follow the instructions below when using Adapt Line support surfaces to ensure the Microclimate Management function is not inadvertently turned off. Temporary actions Until Agiliti is able to install updated software on devices in your possession to correct the issue, please do the following to ensure that the Microclimate function is restored after using Autofirm. After using Autofirm (if the 10-minute timer elapses) 1. Press the Microclimate Management button to toggle the function on. 2. Verify the indicator light next to the Microclimate Button is illuminated. 3. Verify all previous therapy settings have been restored." For questions regarding this Notice or the Recalled Device, please contact your local Service Representative or the Agiliti customer care team: " Email: AFCA0001@agilitihealth.com " Phone: 800-814-9389, option 3
• Quantity in Commerce: 4286
• Distribution: US Nationwide distribution.
• 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.