FDA-Device2026-03-04Class IIPROCESSING DEFECT

Agiliti Health Adapt Pump recalled for temperature control malfunction

OTHERNationwide distributionMedical devices

What this means

Agiliti Health's Adapt Pump (used in Adapt Air and Adapt Convertible mattresses) has a software issue that prevents the temperature control (Microclimate Management) function from restarting after the Autofirm button is used for 10 minutes during initial setup. This only happens if you let the timer run out without manually stopping it, and it only affects temperature management—not the mattress's air support.

  • Check if your mattress pump was made before December 4, 2025 (see the UDI label: 0084569904914)
  • If affected, avoid using the Autofirm function alone during setup, or manually press Autofirm again before the 10-minute timer ends
  • Contact Agiliti Health for a software update or replacement pump
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The agency's original wording
Hazard

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.

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
4286
Manufactured in
204 W 2nd St, N/A, Ellis, KS, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1472-2026

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