Medline Industries, Inc. DYNJ66298DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10195327095895), received between Aug 11, 2026 and Aug 11, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unclear Information” (1 report).

3 FDA recall records name this device's identifier, 3 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. Jan 7, 2026Class IIOpen, Classified

   Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

   Z-2109-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Jan 7, 2026Class IIOpen, Classified

   Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

   Z-1415-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. 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-1091-2023 · 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.

• MalfunctionAug 11, 2026Unclear Information

  It was reported that they recently opened a DaVinci pack, and the trocar was not packaged separately and sterile.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50214530 ↗