Medline MDS9380LFRecalls & reported problems
Medline Industries, Inc. · ANEROID,HAND HELD,ADULT,NEOPRENE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10080196738922), received between Sep 8, 2026 and Sep 30, 2026 — classified as 32 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (17 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
Most reported problems
Device problems
- Gas/Air Leak17
- Incorrect, Inadequate or Imprecise Result or Readings4
- Inflation Problem3
- Obstruction of Flow3
- Physical Resistance/Sticking3
- Unable to Obtain Readings3
- Break2
- Low Readings2
Patient problems
- No Clinical Signs, Symptoms or Conditions32
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Low Readings; Failure to Deflate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953687 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952570 ↗MalfunctionSep 30, 2026Gas/Air Leak
It was reported that "We have a defective adult bp cuff that does not inflate properly."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951875 ↗MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951333 ↗MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950015 ↗MalfunctionSep 29, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937105 ↗MalfunctionSep 29, 2026Inflation Problem; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936604 ↗MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917540 ↗MalfunctionSep 25, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906011 ↗MalfunctionSep 24, 2026Inflation Problem; Gas/Air Leak; Physical Resistance/Sticking
It was reported that "Not inflating- bulb sticks."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889552 ↗MalfunctionSep 24, 2026Gas/Air Leak
It was reported that "the air is exiting the top of if the pump instead og going into the hose".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884073 ↗MalfunctionSep 24, 2026Gas/Air Leak
It was reported that 3 BP cuffs not working properly. Not holding air.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877266 ↗MalfunctionSep 23, 2026Unable to Obtain Readings
It was reported that "When they tested the BP cuff they weren't getting any readings or hear anything."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872708 ↗MalfunctionSep 23, 2026Gas/Air Leak
It was reported that "It is leaking air so it does not fill up and the dial doesn't move."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870446 ↗MalfunctionSep 22, 2026Obstruction of Flow; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859991 ↗MalfunctionSep 22, 2026Calibration Problem
It was reported that the dial starts all the way over at 300 at rest.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855466 ↗MalfunctionSep 21, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848533 ↗MalfunctionSep 18, 2026Break
It was reported that "THE CUFF WONT GO DOWN PAST 200 ON THE METER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818537 ↗MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that "ABOUT 2 WEEKS AGO, THE METER STOPPED GOING UP WHEN PUMPING THE BULB."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818204 ↗MalfunctionSep 17, 2026Gas/Air Leak
It was reported that CUFF DOES NOT FULLY INFLATE AND WILL NOT HOLD AIR. DIAL DOES NOT MOVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50801159 ↗MalfunctionSep 16, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790922 ↗MalfunctionSep 16, 2026Inflation Problem; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788249 ↗MalfunctionSep 16, 2026Failure to Recalibrate; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787702 ↗MalfunctionSep 15, 2026Component Missing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777691 ↗MalfunctionSep 14, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760899 ↗
Other blood pressure cuff devices
- Medline MDS9380Medline Industries, Inc. · blood pressure cuff108 reports
- ONE-CUF ONE-A2-2AGE Medical Systems Information Technologies, Inc. · Blood Pressure Cuff1 recall1 report
- ONE-CUF ONE-A3-2AGE Medical Systems Information Technologies, Inc. · Blood Pressure Cuff1 recall0 reports
- Radius VSM 4826Masimo Corporation · blood pressure cuff1 recall0 reports
- ONE-CUF ONE-A2-2A-LGE Medical Systems Information Technologies, Inc. · Blood Pressure Cuff1 recall0 reports
- ONE-CUF ONE-A3-1BGE Medical Systems Information Technologies, Inc. · Blood Pressure Cuff1 recall0 reports
- Radius VSM 4825Masimo Corporation · blood pressure cuff1 recall0 reports
- Welch Allyn, Inc. 901091Welch Allyn, Inc. · blood pressure cuff1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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