Z-1472-2026Class II

Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt...

Name: Z-1472-2026 Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt...
Creator: Agiliti Health - Ellis
Published: 2026-01-21
License: https://open.fda.gov/license/

Agiliti Health - Ellis / initiated 2026-01-21 / Open, Classified / root cause: software

FDA source

Agiliti Health - Ellis began a recall of 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... on 2026-01-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1472-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-21
Posted: 2026-02-26
Recalling firm: Agiliti Health - Ellis
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
Product code: FNM Mattress, Air Flotation, Alternating Pressure
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.
Root cause tag: software
FDA root 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: [email protected] " Phone: 800-814-9389, option 3
Quantity in commerce: 4286
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI 0084569904914; All serial numbers with a manufacturing date prior to 12/04/2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1472-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1472-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-26

Product code FNM

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 2026-09-05. View this recall on fda.gov (opens on fda.gov)