Medline Industries, Inc. DYNJ50468DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489733334), received between Mar 4, 2024 and Mar 4, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2024Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE CUSTOMER ON AN UNKNOWN DATE, THE SURGEON WAS MAKING AN INCISION TO COMPLETE TEAR IN SHOULDER" WHEN THE "11 BLADE BROKE IN HALF WHILE INSIDE THE PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18828740 ↗
• MalfunctionMar 4, 2024Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE CUSTOMER ON (B)(6) 2024, "THE SURGEON WAS MAKING AN INCISION TO COMPLETE TEAR IN SHOULDER" WHEN THE "11 BLADE BROKE IN HALF WHILE INSIDE THE PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18827849 ↗