PlainRecordsAdapt Pump…
- Reason
- 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…
- Status
- Ongoing
- Distribution
- US Nationwide distribution.
- Enforcement report date
- March 4, 2026
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- 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
- Reason
- 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.
- Distribution pattern
- US Nationwide distribution.
- Quantity
- 4286
- Codes and lots
- UDI-DI 0084569904914; All serial numbers with a manufacturing date prior to 12/04/2025
- Recall started
- Jan. 21, 2026
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Mattress, Air Flotation, Alternating Pressure
- Root cause (FDA)
- Software design
- What the company told customers
- 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
- Recall number
- Z-1472-2026
What this record is about
A generic icon of the kind of thing the record is about; the record's own words are below. It is not a picture of the product.
“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.”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, FDA enforcement report, 2026-03-04. The caption is the record's own words.
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FDA device name: Mattress, Air Flotation, Alternating Pressure
This recall among the others
- FDA's enforcement report came 42 days after the firm started the recall. For half of the 860 FDA medical device recall events reported in 2026 so far with a start date, it took 49 days or fewer (by year).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement report, recall number Z-1472-2026. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-1472-2026, March 4, 2026. "Adapt Pump." PlainRecords, https://plainrecords.com/recall/device/z-1472-2026/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections