Medline MDS9388Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10080196177813), received between Sep 8, 2026 and Sep 30, 2026 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (21 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Gas/Air Leak; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951965 ↗
• MalfunctionSep 29, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937446 ↗
• MalfunctionSep 29, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936421 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936387 ↗
• MalfunctionSep 28, 2026High Readings

  It was reported that "the 1 they are using is not reading correctly (getting high BP readings)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915817 ↗
• MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that it was misreading.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896698 ↗
• MalfunctionSep 24, 2026Inflation Problem; Gas/Air Leak

  This summary report covers malfunction events that occurred between July 1 and September 30, 2024. This VMSR summarizes one malfunction event involving three Medline hand-held aneroid sphygmomanometers (catalog number MDS9388). The account reported that a unit would not inflate. Three devices were returned and evaluated. The reported malfunction was not confirmed. No patient information was available. No patient or user injuries were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889277 ↗
• MalfunctionSep 24, 2026Gas/Air Leak

  It was reported that the bladders are leaking on both of these.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889233 ↗
• MalfunctionSep 24, 2026Material Puncture/Hole; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883582 ↗
• MalfunctionSep 23, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875352 ↗
• MalfunctionSep 23, 2026Gas/Air Leak; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872580 ↗
• MalfunctionSep 23, 2026Inflation Problem; Unable to Obtain Readings

  It was reported that "We just opened 2 new ones and one doesn't pump and one is stuck at 225."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871223 ↗
• MalfunctionSep 23, 2026Break

  It was reported that "the blood pressure guage doesnt work at all. cuff does inflate."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869634 ↗
• MalfunctionSep 22, 2026Break; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859879 ↗
• MalfunctionSep 22, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859630 ↗
• MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "1 BP UNIT IS DEFECTIVE AS IT'S Not getting accurate readings."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858545 ↗
• MalfunctionSep 22, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857924 ↗
• MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings; Naturally Worn

  It was reported that "Worn and not recording appropriately."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856815 ↗
• MalfunctionSep 22, 2026Material Split, Cut or Torn

  It was reported that "wont inflate."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856396 ↗
• MalfunctionSep 21, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840815 ↗
• MalfunctionSep 21, 2026Material Puncture/Hole

  It was reported that both of the BP cuffs have gotten holes in them after only using them a few times.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838117 ↗
• MalfunctionSep 18, 2026Inflation Problem; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829640 ↗
• MalfunctionSep 17, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808634 ↗
• MalfunctionSep 16, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790444 ↗
• MalfunctionSep 15, 2026Inflation Problem; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779877 ↗