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Medline MDT24A20Recalls & reported problems

Medline Industries, Inc. · MATTRESS,SYSTEM,A20,LAL/ALTERNATING PRES · Class 2

Quick summary

This Medline alternating air mattress is used for pressure relief. The reports mostly describe the mattress losing air or deflating, sometimes not holding pressure when alternating. There are 78 reports, no deaths, 8 injuries, and 69 malfunctions; no recalls name this device. Reports increased sharply, with 69 in the last 12 months versus 2 in the previous 12 months.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
267
Deaths reported
0
Injuries reported
8
Recalls naming it
0

Summary

The FDA's MAUDE database contains 267 adverse event reports that list this exact device (DI 10080196549733), received between Apr 14, 2020 and Sep 30, 2026 — classified as 8 injuries, 255 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (85 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 8 reportsJun 2026: 2 reportsJul 2026: 7 reportsAug 2026: 50 reportsSep 2026: 189 reportsOct 2026: 0 reports202420252026189
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Gas/Air Leak85
  • Inflation Problem77
  • Deflation Problem39
  • Unintended Deflation36
  • Decrease in Pressure30
  • Material Split, Cut or Torn13
  • Decreased Pump Speed8
  • Pumping Problem8

Patient problems

  • No Clinical Signs, Symptoms or Conditions243
  • Pressure Sore/Ulcer6
  • Tissue Breakdown5
  • Ulcer5
  • Impaired Healing3
  • Back pain2
  • Sleep Dysfunction2
  • Pain1

Recent adverse event reports

The 25 most recent of 267 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 30, 2026Deflation Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50952419 ↗
  • MalfunctionSep 30, 2026Gas/Air Leak

    It was reported that The Yellow Light Indicator is on, meaning the mattress is not getting enough air. The customer already checked the CPR and Valves; they are all connected.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50951544 ↗
  • MalfunctionSep 30, 2026Gas/Air Leak

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50951355 ↗
  • MalfunctionSep 30, 2026Inflation Problem

    It was reported that "Shows green light but there are several flat cells."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50947265 ↗
  • MalfunctionSep 30, 2026Inadequate Instructions for Non-Healthcare Professional

    It was reported that the mattress is leaking.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50946689 ↗
  • MalfunctionSep 30, 2026Inflation Problem; Unintended Deflation

    It was reported that "There was an area that did not inflate and caused sinking where my mom¿s bed sore was."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50946246 ↗
  • MalfunctionSep 29, 2026Deflation Problem; Decrease in Pressure

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50938078 ↗
  • MalfunctionSep 29, 2026Deflation Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50934145 ↗
  • MalfunctionSep 29, 2026Decrease in Pressure

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50933317 ↗
  • MalfunctionSep 29, 2026Unintended Deflation

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50932182 ↗
  • MalfunctionSep 29, 2026Unintended Deflation

    This VMSR report summarizes 2 malfunction events that occurred during Q4 2025 ((b)(6) 31, 2025). The account reported that two mattress systems were going flat in the middle. The customer requested replacement of both mattresses due to loss of support in the center section. The reported condition was identified prior to any reported injury. Samples were reported as available for evaluation. The complaint was subsequently reviewed for lot information and warranty status. No patient age, weight, sex, race, or ethnicity information was available. No patient or user injuries were reported.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50931794 ↗
  • MalfunctionSep 29, 2026Deflation Problem; Inflation Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50931017 ↗
  • MalfunctionSep 28, 2026Pumping Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50920054 ↗
  • MalfunctionSep 28, 2026Inflation Problem; Gas/Air Leak

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50916976 ↗
  • MalfunctionSep 28, 2026Pumping Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50916949 ↗
  • MalfunctionSep 28, 2026Gas/Air Leak

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50916222 ↗
  • MalfunctionSep 28, 2026Inflation Problem

    It was reported that the device was "Not fully inflating."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50915949 ↗
  • MalfunctionSep 28, 2026Pumping Problem

    It was reported that Air mattress is getting deflated from center. Pump shows low pressure but as soon as patient lies on the mattress it deflates from the center.

    Patient problems: Impaired Healing; Tissue Breakdown

    MAUDE report 50913721 ↗
  • MalfunctionSep 28, 2026Inflation Problem; Unintended Deflation

    It was reported that "THE SYSTEM LOSES AIR."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50912902 ↗
  • MalfunctionSep 26, 2026Decrease in Pressure

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50906425 ↗
  • MalfunctionSep 25, 2026Material Deformation

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50906277 ↗
  • MalfunctionSep 25, 2026Gas/Air Leak

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50906169 ↗
  • MalfunctionSep 25, 2026Unintended Deflation

    Patient problems: Tissue Breakdown

    MAUDE report 50905549 ↗
  • MalfunctionSep 25, 2026Inflation Problem

    It was reported that she took it out of the box and it was not working (it was not holding air). The cells in the mattress aren¿t inflating and when they do they are not keeping the air.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50902454 ↗
  • MalfunctionSep 25, 2026Gas/Air Leak

    It was reported that the mattress is not holding air.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50899597 ↗

Other MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE devices

All MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.