Medline Industries, Inc. DYNJ0151255ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889942245611), received between May 3, 2019 and May 3, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. Nov 17, 2022Class IIOpen, Classified

   Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

   Z-1096-2023 · Root cause: Device Design · 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.

• MalfunctionMay 3, 2019Break; Material Fragmentation

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SURGICAL BLADE BROKE AND PIECES FELL INTO THE SURGICAL SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8577317 ↗