Medline Industries, Inc. DYNJ44700JRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10195327277413), received between Aug 11, 2026 and Aug 11, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Adhesive Too Strong” (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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 7, 2026Open, 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-2092-2026 · Root cause: Process control · FDA record ↗

2. Jan 7, 2026Open, 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-1389-2026 · Root cause: Under Investigation by firm · FDA record ↗

3. May 18, 2023Open, Classified

   Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

   Z-2160-2023 · Root cause: Device Design · 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, 2026Adhesive Too Strong

  It was reported that drape is sticky when draping the patient causing issues with staff, pulling, keeping the drape in place and sterility.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50214086 ↗