Medline Industries, Inc. DYNJ61124DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10195327561109), received between Apr 22, 2026 and Apr 22, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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. May 4, 2026Class IIOpen, Classified

   During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

   Z-2487-2026 · Root cause: Nonconforming Material/Component · 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-2093-2026 · Root cause: Process control · Recall details · FDA record ↗

3. 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-1390-2026 · Root cause: Under Investigation by firm · 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.

• MalfunctionApr 22, 2026Delivered as Unsterile Product; Expiration Date Error

  IT WAS REPORTED ON (B)(6) THAT AN EXPIRED PRODUCT FROM THE OPEN HEART TRAY WAS USED ON A PATIENT. THE EXPIRED STATUS WAS IDENTIFIED AFTER USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957023 ↗