Medline MDS91423Recalls & reported problems
Medline Industries, Inc. · SET, BP, CUFF, BLD, PVC, 2T, LG ADL · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10080196717613), received between Sep 14, 2026 and Sep 29, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (4 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 Leak4
- Material Split, Cut or Torn2
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
OtherSep 29, 2026Gas/Air Leak
It was reported that "CUFFS STOPPED FUNCTIONING WITHIN A WEEK. THE BULB ATTACHED TO THE TUBING WILL NOT REOPEN, THE CUFFS DO NOT HOLD AIR PRESSURE.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932209 ↗MalfunctionSep 25, 2026Gas/Air Leak; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906003 ↗MalfunctionSep 14, 2026Gas/Air Leak; Material Split, Cut or Torn
It was reported that the Adult Large (MDS91423, Lot: 65123110001) was put into service on 3/13/2024 and now has a hole in the bladder, requiring it to be taken out of service.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755972 ↗MalfunctionSep 14, 2026Incorrect, Inadequate or Imprecise Result or Readings; Gas/Air Leak
It was reported that "BP cuff defective, no longer working. Air comes out. Reading is off."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753145 ↗
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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