Medline Industries, Inc. DYNJ0545064YRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489469042), received between Mar 25, 2024 and Apr 3, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 27, 2026Open, Classified

   Unapproved design changes to the products outside of the 510(k) clearance.

   Z-1877-2026 · Root cause: Component change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2024Break; Break

  IT WAS REPORTED THAT THE SYRINGE TIP IS "BREAKING".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19036219 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT A LUER LOCK SYRINGE COMPONENT "BROKE OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18976245 ↗