Medline Industries, Inc. DYNJ61995FRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10195327063436), received between Aug 10, 2026 and Aug 10, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Remains Activated” (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

1. Mar 19, 2026Class IIOpen, Classified

   During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

   Z-2038-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Device Remains Activated

  It was reported that "During two surgical cases in two different rooms with two different ESU/bovie machines, the cautery handpiece from the Custom MP Spine pack would not turn off once triggered." "Once the handpiece was initially triggered when Dr. Tatsumi released the button, the handpiece continued firing.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50198370 ↗