Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Ada
Summary
The FDA issued a Class II for Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt suppor by Agiliti Health - Ellis. Reason: Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support surfaces does not re-engage the Microclima.
Details
Source
Device Recall
External ID
Z-1472-2026
Action Date
2026-03-04
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: UDI-DI 0084569904914; All serial numbers with a manufacturing date prior to 12/04/2025
Quantity Affected: 4286
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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-21
Company
Ellis, KS
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 178 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Agiliti Health - Ellis) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Agiliti Health - Ellis have FDA actions?
This is the only FDA action we have on record for Agiliti Health - Ellis in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1472-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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