HIGHFDA DEVICE

Agiliti Recalls Adapt Pump Over Microclimate Management Failure

Agiliti Health recalled 4,286 Adapt Pumps on January 21, 2026, after identifying a malfunction. The issue prevents the Microclimate Management function from re-engaging following the Autofirm function. This defect poses a risk to patients relying on the device for safe pressure management.

Official notice
Agiliti Health - EllisHealth & Personal CareMedical DevicesUDI-DI 0084569904914All serial numbers with a manufacturing date prior to 12/04/2025

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
January 21, 2026
Status
ACTIVE
Severity
6/10

Quick Facts at a Glance

Recall Date
January 21, 2026
Hazard Level
HIGH
Brand
Agiliti Health - Ellis
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Agiliti Health - Ellis
Product type
Adapt Pump
Model numbers
UDI-DI 0084569904914, All serial numbers with a manufacturing date prior to 12/04/2025
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    January 21, 2026

  2. Reported by FDA DEVICE

    March 4, 2026

  3. RecallRadar source check

    March 11, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Agiliti Health - Ellis or your healthcare provider for instructions. Notification method: E-Mail

About This Product

The Adapt Pump is a medical device used in conjunction with support surfaces to provide alternating pressure for patients at risk of pressure sores. Healthcare providers utilize this device to enhance patient comfort and care during recovery.

Why This Is Dangerous

The malfunction prevents the device from re-engaging essential functions that regulate temperature and moisture, which are critical for patient safety and comfort.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients relying on the Adapt Pump may experience discomfort and increased risk of pressure-related injuries if the device is not functioning as intended. Immediate action is required to ensure patient safety.

Practical Guidance

How to identify if yours is affected

  1. Verify the model number is 61600200.
  2. Check the manufacturing date on the device to see if it is before 12/04/2025.
  3. Confirm if the device has been used with the Autofirm function.

Where to find product info

The serial number can usually be found on the back or bottom of the Adapt Pump. Refer to the user manual for exact locations.

What timeline to expect

Expect a refund or replacement processing time of approximately 4-6 weeks after submission.

If the manufacturer is unresponsive

  • Contact Agiliti Health again using different contact methods.
  • Document all correspondence and keep records of your requests.

How to prevent similar issues

  • Look for safety certifications when purchasing medical devices.
  • Choose products that offer clear user instructions and support services.
  • Research customer reviews for reliability and effectiveness.

Documentation advice

Keep records of photos of the device, any correspondence related to the recall, and receipts if available.

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

Product Details

The recall affects Adapt Pump, Model Number: 61600200-Adapt Pump, which is part of the Adapt support surfaces including Adapt Air and Adapt Pro. These devices were distributed nationwide in the United States.

Key Facts

  • Recall date: January 21, 2026
  • Affected models: All Adapt Pumps with serial numbers before 12/04/2025
  • Malfunction affects Microclimate Management function

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
6/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
UDI-DI 0084569904914
All serial numbers with a manufacturing date prior to 12/04/2025
Affected States
ALL
Report Date
March 4, 2026
Recall Status
ACTIVE

Related Recalls

Health & Personal Care
MEDIUM

AvKARE Recalls Rosuvastatin Tablets Due to Dissolution Issues

AvKARE recalled 7,991 cartons of Rosuvastatin Tablets on December 31, 2025. The recall stems from the product being out of specification for dissolution. Consumers should stop using the medication immediately and consult healthcare providers for guidance.

LACTATED RINGERS
Presence of
Read more