Medline Industries, Inc. DYNJ908452Recalls & reported problems
Medline Industries, Inc. · TONSIL · 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10195327073602), received between Jun 22, 2022 and Jun 22, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fire” (1 report).
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.
Recalls naming this device
- May 4, 2026Class IIOpen, Classified
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Z-2491-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Fire1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 22, 2022Fire
IT WAS REPORTED THAT DURING THE BEGINNING OF A TONSILLECTOMY/ADENOIDECTOMY, THE SURGEON NOTICED A SMALL FLAME AT THE TIP OF THE BOVIE WHEN HE ACTIVATED THE DEVICE. NO INJURY WAS NOTED TO THE PATIENT, THE DEVICE WAS IMMEDIATELY REMOVED FROM SERVICE AND REPLACED WITH A NEW BOVIE PENCIL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14776779 ↗
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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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