MEDLINE 60022681BRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10197344009299), received between Jun 18, 2024 and Mar 16, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (3 reports).

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. 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-2144-2026 · Root cause: Under Investigation by firm · FDA record ↗

2. 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 ↗

3. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Connection Problem

  SYRINGE CONNECTION ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607276 ↗
• MalfunctionJul 23, 2024Connection Problem; Connection Problem

  SYRINGE NOT STAYING CONNECTED.

  Patient problems: Insufficient Information

  MAUDE report 19811411 ↗
• MalfunctionJul 19, 2024Break; Break

  IT WAS REPORTED ON (B)(6) 2024 THE "DOCTOR PULLED BACK PLUNGER OF SYRINGE AND IT BROKE APART".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19782064 ↗
• MalfunctionJun 18, 2024Connection Problem; Connection Problem

  SYRINGE CONNECTION ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19561387 ↗