MEDLINE 601006269Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10193489189582), received between Jul 9, 2024 and Sep 30, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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 16, 2026.

Recalls naming this device

1. Mar 24, 2026Class IOpen, Classified

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

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

2. Mar 24, 2026Class IOpen, Classified

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

   Z-2144-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Feb 27, 2026Class IOpen, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Crack

  It was reported that the 6" connecting tube cracked when attaching to the manifold syringe. Syringe was drawing air.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947577 ↗
• MalfunctionSep 25, 2026Failure to Zero

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902608 ↗
• MalfunctionJul 9, 2024Connection Problem; Connection Problem

  ACCORDING TO THE CUSTOMER, "THREADS ON CONTROL SYRINGE WERE DAMAGED ON ONE AND THE SYRINGE BACKED ITSELF OFF OF THE MANIFOLD AFTER BEING FULLY THREADED ON".

  Patient problems: Insufficient Information

  MAUDE report 19701904 ↗