Medline MDS9388LFRecalls & reported problems
Medline Industries, Inc. · ANEROID,HAND HELD,LRG ADULT,NEOPRENE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10080196738953), received between Sep 8, 2026 and Sep 28, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Inflation Problem2
- Calibration Problem1
- Gas/Air Leak1
- Mechanical Jam1
- Unable to Obtain Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923291 ↗MalfunctionSep 25, 2026Break
It was reported that the guage is stuck at 300 and will not move. this was noticed right after unboxing the item.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896322 ↗MalfunctionSep 24, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890092 ↗MalfunctionSep 22, 2026Unable to Obtain Readings
It was reported that "Every time we pump, the arrow doesn't move."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854062 ↗MalfunctionSep 17, 2026Inflation Problem; Gas/Air Leak
It was reported that CUFFS WERE NOT INFLATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803615 ↗MalfunctionSep 8, 2026Inflation Problem; Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674488 ↗
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- Welch Allyn, Inc. 901091Welch Allyn, Inc. · blood pressure cuff1 recall0 reports
- Welch Allyn, Inc. 901091Welch Allyn, Inc. · blood pressure cuff1 recall0 reports
- ONE-CUF ONE-A2-2A-LGE Medical Systems Information Technologies, 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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