Medline Industries, Inc. DYNJ0378527QRecalls & reported problems
Medline Industries, Inc. · DELIVERY PACK-LF · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10193489219302), received between Jul 1, 2024 and Jul 1, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 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
- Material Split, Cut or Torn3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 1, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED WHEN ATTEMPTING TO SUCTION THE EARS AND NOSE OF A "NEWBORN" THE SUCTION WAS NOT WORKING DUE TO THE BULB BEING "SEPARATED".
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19650938 ↗InjuryJul 1, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED ON (B)(6) 2024 WHEN ATTEMPTING TO SUCTION THE EARS AND NOSE OF A "NEWBORN" THE SUCTION WAS NOT WORKING DUE TO THE BULB BEING "SEPARATED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19650576 ↗MalfunctionJul 1, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED ON (B)(6) 2024 WHEN ATTEMPTING TO SUCTION THE EARS AND NOSE OF A "NEWBORN" THE SUCTION WAS NOT WORKING DUE TO THE BULB BEING "SEPARATED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19648700 ↗
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- Medline Industries, Inc. PAIN1699AMedline Industries, Inc. · Labor and Delivery Kit2 recalls0 reports
- Medline Industries, Inc. DYNJ68663Medline Industries, Inc. · Labor and Delivery Kit2 recalls0 reports
- Centurion MNS8950ACenturion Medical Products Corporation · Labor and Delivery Kit2 recalls0 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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