Medline Industries, Inc. DYNJ63487ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10193489477153), received between Jun 8, 2022 and Jun 8, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Frayed” (1 report).

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. 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 ↗

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.

• InjuryJun 8, 2022Material Frayed

  IT WAS REPORTED THAT THE GAUZE WAS FRAYING AND RELEASING FRAGMENTS INTO THE WOUND DURING USE. NO ADDITIONAL DETAILS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14631572 ↗