Medline MDS9400Recalls & reported problems
Medline Industries, Inc. · ANEROID,WALL MOUNT,ADULT CUFF · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 30080196771268), received between Sep 2, 2026 and Sep 30, 2026 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (14 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.
Reports received per month
Most reported problems
Device problems
- Gas/Air Leak14
- Calibration Problem4
- High Readings4
- Incorrect, Inadequate or Imprecise Result or Readings4
- Mechanical Jam3
- Inflation Problem2
- Material Split, Cut or Torn2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- High Blood Pressure/ Hypertension1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Inflation Problem; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949638 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933482 ↗MalfunctionSep 26, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906501 ↗MalfunctionSep 24, 2026Inflation Problem; Obstruction of Flow; Gas/Air Leak
It was reported that THE CUFF/UNIT WILL NOT INFLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885292 ↗MalfunctionSep 24, 2026Calibration Problem
It was reported that "HE IS DOING AN ISPECTION ON PRODUCTS AND STATS IT IS 8MMHG OFF."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882898 ↗MalfunctionSep 22, 2026High Readings
It was reported that "They read significantly higher than they should be for patients and are not interchangeable for different size patients" and "They read at least 20 higher on systolic than the person probably has".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858804 ↗MalfunctionSep 18, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831082 ↗MalfunctionSep 18, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829316 ↗MalfunctionSep 18, 2026Material Separation; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820054 ↗MalfunctionSep 17, 2026Gas/Air Leak; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809264 ↗MalfunctionSep 17, 2026High Readings
Patient problems: High Blood Pressure/ Hypertension
MAUDE report 50807567 ↗MalfunctionSep 16, 2026High Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787645 ↗MalfunctionSep 16, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787249 ↗MalfunctionSep 15, 2026High Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776870 ↗MalfunctionSep 15, 2026Gas/Air Leak; Material Split, Cut or Torn
It was reported that "The cuff is not holding air and it deflates as they are pumping it up."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775574 ↗MalfunctionSep 14, 2026Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762059 ↗MalfunctionSep 14, 2026Gas/Air Leak
It was reported that the cuff is leaking air and can pump it up but the edge is leaking.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753341 ↗MalfunctionSep 14, 2026Gas/Air Leak
It was reported that "The cuff has another leak"; "and when it reached 180 the needle started to fall without them releasing the air themselves"; and "They could hear and feel the air leaking from the cuff."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747993 ↗MalfunctionSep 11, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736579 ↗MalfunctionSep 11, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734500 ↗MalfunctionSep 11, 2026Material Puncture/Hole; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733593 ↗MalfunctionSep 10, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720623 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564279 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564278 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564276 ↗
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-P1-2AGE Medical Systems Information Technologies, Inc. · Blood Pressure Cuff1 recall0 reports
- ONE-CUF ONE-A1-1BGE Medical Systems Information Technologies, Inc. · Blood Pressure Cuff1 recall0 reports
- ONE-CUF ONE-P1-1BGE Medical Systems Information Technologies, Inc. · Blood Pressure Cuff1 recall0 reports
- ONE-CUF ONE-A2-2A-LGE Medical Systems Information Technologies, Inc. · Blood Pressure Cuff1 recall0 reports
- ONE-CUF ONE-A3-2AGE Medical Systems Information Technologies, Inc. · Blood Pressure Cuff1 recall0 reports
- Radius VSM 4826Masimo Corporation · 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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