Medline MDS9410Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00080196773193), received between Sep 12, 2026 and Sep 30, 2026 — classified as 30 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Gas/Air Leak

  It was reported that customer received defective blood pressure cuffs.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951609 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that "the newer blood pressure cuffs we are using are going out at a quicker rate than they used to" and "The cuffs will still look brand new but will have issues like: Leaking bladder, Meters out of configuration, The screw ball that keeps the air pressure will release at a faster than normal rate so they¿re unable to capture or ensure accuracy of the readings".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946830 ↗
• MalfunctionSep 30, 2026Deflation Problem; Inflation Problem; Gas/Air Leak

  It was reported that "BP pressure cuff not deflaiting or inflating to it normal standards. Air stays in the cuff, and it does not inflate to its standard max pressure".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946030 ↗
• MalfunctionSep 29, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933007 ↗
• MalfunctionSep 25, 2026Material Puncture/Hole

  It was reported that "THIS ARRIVED WITH A HOLE IN THE TUBING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904163 ↗
• MalfunctionSep 24, 2026Calibration Problem

  It was reported that "THE NEEDLE EITHER STICKS OR THE UNIT DOESNT PUMP UP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889211 ↗
• MalfunctionSep 23, 2026Inflation Problem; Gas/Air Leak

  It was reported that "CUST THINKS THAT THERE MAY BE A HOLE, IT DOESN'T STAY INFLATED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872064 ↗
• MalfunctionSep 23, 2026Calibration Problem

  It was reported that "item is not calibrating correctly."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868556 ↗
• MalfunctionSep 23, 2026Gas/Air Leak

  It was reported that "None of them are working correctly" and "They are not holding air." "At least one of them has a noticeable hole in the tubing, not sure if there are pin point holes in the others."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867987 ↗
• MalfunctionSep 22, 2026Incorrect Measurement

  It was reported that BP GAUGE ON CUFF DOES NOT WORK, DOES NOT READ BP CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857653 ↗
• MalfunctionSep 21, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842004 ↗
• MalfunctionSep 21, 2026Inflation Problem; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840496 ↗
• MalfunctionSep 21, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838535 ↗
• MalfunctionSep 18, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829005 ↗
• MalfunctionSep 17, 2026Gas/Air Leak

  It was reported that customer received defective blood pressure cuffs.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806221 ↗
• MalfunctionSep 17, 2026Inflation Problem; Gas/Air Leak

  It was reported that "The nurse went to blow the BP Cuff up and it is \"blown out.\" The nurse said the BP guage should be at 0 and it is reading 280 right now, won't pump up."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50804932 ↗
• MalfunctionSep 17, 2026Gas/Air Leak

  It was reported that "I have an adult BP cuff item # (b)(6) that has a leak and is unable to hold air."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803325 ↗
• MalfunctionSep 17, 2026Gas/Air Leak

  It was reported that "The bladders are leaking on all of them."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803204 ↗
• MalfunctionSep 16, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794943 ↗
• MalfunctionSep 16, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793830 ↗
• MalfunctionSep 16, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793792 ↗
• MalfunctionSep 16, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792724 ↗
• MalfunctionSep 15, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779398 ↗
• MalfunctionSep 15, 2026Incorrect, Inadequate or Imprecise Result or Readings; Material Split, Cut or Torn

  It was reported that "PRODUCT NO LONGER HOLDING AIR WHEN USING. PRODUCT WILL DEFLATE AND NOT TAKE ACCURATE BLOOD PRESSURE READING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771474 ↗
• MalfunctionSep 15, 2026Gas/Air Leak

  It was reported that bp cuff is not inflating or providing correct readings; stuck at 40 when completely deflated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766390 ↗