MEDLINE INDUSTRIES, INC. DYNJ04230Recalls & reported problems
Medline Industries, Inc. · HOOK,AMNIO,PLASTIC,STERILE · Class 1
Data updated Oct 18, 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 10080196820764), received between Jun 28, 2026 and Jul 6, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Lack of Effect” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Lack of Effect4
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.
MalfunctionJul 6, 2026Lack of Effect
IT WAS REPORTED THAT THE AMNIO HOOK WAS NOT SHARP ENOUGH TO RUPTURE THE AMNIOTIC SAC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25727671 ↗MalfunctionJul 6, 2026Lack of Effect
IT WAS REPORTED THAT THE AMNIO HOOK WAS NOT SHARP ENOUGH TO RUPTURE THE AMNIOTIC SAC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25727669 ↗MalfunctionJul 6, 2026Lack of Effect
IT WAS REPORTED THAT THE AMNIO HOOK WAS NOT SHARP ENOUGH TO RUPTURE THE AMNIOTIC SAC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25727667 ↗MalfunctionJun 28, 2026Lack of Effect
IT WAS REPORTED THAT THE AMNIO HOOK WAS NOT SHARP ENOUGH TO RUPTURE THE AMNIOTIC SAC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25648383 ↗
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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