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Medline MDS9973Recalls & reported problems

Medline Industries, Inc. · CUFF,BP,EXTRA LARGE ADULT, FOR MDS3001 · Class 2

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

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10080196721900), received between Sep 11, 2026 and Sep 29, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (2 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: 0 reportsSep 2026: 4 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Inflation Problem2
  • Unable to Obtain Readings2
  • Gas/Air Leak1
  • Incorrect, Inadequate or Imprecise Result or Readings1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 29, 2026Inflation Problem; Gas/Air Leak

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50936785 ↗
  • MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

    It was reported that the product was "Not working properly, goes too tight on the arm and doesn't allow for proper reading on blood pressure monitors."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50899511 ↗
  • MalfunctionSep 11, 2026Inflation Problem; Unable to Obtain Readings

    It was reported that "The BP cuff is not working properly.From what I¿ve gathered from our clinical team they press start to check blood pressure and it does not trigger the cuff to tighten."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50736886 ↗
  • MalfunctionSep 11, 2026Unable to Obtain Readings

    It was reported that the blood pressure cuff gets no results, it goes through the process of taking the readings, but no results come at the end.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50732876 ↗

Other SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE devices

All SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE devices →

Sources and updates

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