NAMIC 60131554Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10193489046939), received between May 16, 2024 and Sep 25, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (4 reports).

2 FDA recall records name this device's identifier, 2 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. Mar 24, 2026Open, Classified

   Medline has identified the presence of particulate within the fluid path of the Manifolds.

   Z-2145-2026 · Root cause: Under Investigation by firm · FDA record ↗

2. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904258 ↗
• MalfunctionMay 16, 2024Connection Problem; Connection Problem

  SYRINGE WOULD NOT STAY ATTACHED TO THE MANIFOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19336796 ↗
• MalfunctionMay 16, 2024Connection Problem; Connection Problem

  SYRINGE WOULD NOT STAY ATTACHED TO THE MANIFOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19336702 ↗
• MalfunctionMay 16, 2024Connection Problem; Connection Problem

  SYRINGE WOULD NOT STAY ATTACHED TO THE MANIFOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19333551 ↗
• MalfunctionMay 16, 2024Connection Problem; Connection Problem

  SYRINGE WOULD NOT STAY ATTACHED TO THE MANIFOLD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19332916 ↗