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Medline MDT24SUPRAEXORecalls & reported problems

Medline Industries, Inc. · OVERLAY,SYSTEM,SUPRA EXO,LAL/ALT. PRESS · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10080196372201), received between May 26, 2021 and Sep 8, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 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: 0 reportsJan 2025: 0 reportsFeb 2025: 0 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: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 3 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Inflation Problem3
  • Unintended Deflation2
  • Failure to Align1
  • Gas/Air Leak1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 8, 2026Inflation Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50674583 ↗
  • MalfunctionSep 8, 2026Inflation Problem; Unintended Deflation

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50670292 ↗
  • MalfunctionSep 1, 2026Unintended Deflation

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50547422 ↗
  • MalfunctionAug 31, 2026Failure to Align; Gas/Air Leak

    It was reported that three of the air valves are sticking straight up out of the mattress and when the patient is placed on the mattress, the air is leaking out of it. She said the valves are supposed to be underneath, but they are positioned wrong.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50525193 ↗
  • MalfunctionMay 26, 2021Inflation Problem

    IT WAS REPORTED THAT THE MATTRESS OVERALL WOULD NOT REMAIN INFLATED.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 11891484 ↗

Other MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE devices

All MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE devices →

Sources and updates

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