MEDLINE 60805108ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489141306), received between Apr 17, 2025 and Apr 18, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Feb 27, 2026Open, Classified

   Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

   Z-1718-2026 · Root cause: Under Investigation by firm · Recall details · 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 18, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE SYRINGE IS "LEAKING CONTRAST AT THE SYRINGE TIP".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865226 ↗
• MalfunctionApr 17, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE SYRINGE IS "LEAKING CONTRAST AT THE SYRINGE TIP".

  Patient problems: Insufficient Information

  MAUDE report 21858971 ↗