Medline Industries, Inc. DYNJ0373237MRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10193489369014), received between Oct 10, 2023 and Oct 10, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Feb 11, 2025Class IIOpen, Classified

   Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

   Z-1438-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Nov 17, 2022Class IIOpen, Classified

   Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

   Z-1067-2023 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  RASH REQUIRING MEDICAL TREATMENT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 17906461 ↗