Medline MDS9413Recalls & reported problems
Medline Industries, Inc. · ANEROID,HANDHELD,PREMIER,LRG ADULT · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00080196743769), received between Sep 9, 2026 and Sep 30, 2026 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (10 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 Leak10
- Inflation Problem3
- Incorrect, Inadequate or Imprecise Result or Readings2
- Activation, Positioning or Separation Problem1
- Calibration Problem1
- Failure to Recalibrate1
- Material Puncture/Hole1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954206 ↗MalfunctionSep 30, 2026Inflation Problem; Gas/Air Leak
It was reported that the device is not inflating properly.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947131 ↗MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936436 ↗MalfunctionSep 29, 2026Material Puncture/Hole; Gas/Air Leak
It was reported that the tub has a crack in it and it won't inflate. Customer emailed in again stating another one of these blood pressure cuffs are defective.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932257 ↗MalfunctionSep 28, 2026Failure to Recalibrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925717 ↗MalfunctionSep 28, 2026Gas/Air Leak
It was reported that "the dial is not working and is at the 240 mark."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913104 ↗MalfunctionSep 22, 2026Calibration Problem
customer is having issues with product and the accuracy
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858256 ↗MalfunctionSep 22, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857756 ↗MalfunctionSep 21, 2026Inflation Problem; Gas/Air Leak
It was reported that the ¿cuff is not working¿.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839976 ↗MalfunctionSep 18, 2026Gas/Air Leak
It was reported that "Will not inflate/hold inflation".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50825982 ↗MalfunctionSep 17, 2026Gas/Air Leak
customer states that the product will not inflate/hold inflation, customer would like a replacement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804978 ↗MalfunctionSep 17, 2026Gas/Air Leak
It was reported that "THERE IS AN ISSUE WITH THE TUBING ON THIS CUFF & IT WILL NOT INFLATE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804851 ↗MalfunctionSep 13, 2026Gas/Air Leak; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747942 ↗MalfunctionSep 11, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741400 ↗MalfunctionSep 10, 2026Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722169 ↗MalfunctionSep 9, 2026Gas/Air Leak
The report states, "Cuffs is not holding air."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50689920 ↗
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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