Medline Industries, Inc. DYNJS3013Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884389201572), received between Oct 25, 2023 and Sep 29, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Heating” (1 report).

2 FDA recall records name this device's identifier, 2 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-2114-2026 · 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-1421-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938584 ↗
• MalfunctionSep 10, 2026Insufficient Heating

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718434 ↗
• InjuryOct 25, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY THE BOVIE PEN SWITCH DID NOT SWITCH OFF AND BURNT A PATIENT AND BURNT THROUGH THE DRAPE.

  Patient problems: Burn(s)

  MAUDE report 18003152 ↗