Medline Industries, Inc. DYNJ38985GRecalls & reported problems
Medline Industries, Inc. · MAJOR HEAD AND NECK PACK · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10195327385682), received between Sep 17, 2026 and Sep 25, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Misassembled” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Apr 27, 2026Class IIOpen, Classified
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Z-2421-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Component Misassembled2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Component Misassembled
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903926 ↗MalfunctionSep 17, 2026Component Misassembled
It was reported that ¿The Bovie pad and Bovie are in the internal ¿sterilized¿ contents¿. It was later reported that ¿It was actually the bovie pad and the individual gown that the staff said was tucked inside the back table cover rather than on top of the pack as usual¿.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804615 ↗
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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 · each recall links to the FDA recall notice
- 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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