Medline Industries, Inc. DYNJ82196Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10195327183509), received between Aug 29, 2023 and Sep 7, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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 18, 2026.

Recalls naming this device

1. Oct 9, 2024Class IIOpen, Classified

   Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

   Z-0633-2025 · 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.

• MalfunctionSep 7, 2023Material Integrity Problem; Material Integrity Problem

  TAIL OF LAP SPONGE FOUND WHICH RESULTED IN ADDITIONAL PROCEDURE TIME AND XRAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17700299 ↗
• InjuryAug 29, 2023Material Integrity Problem; Material Integrity Problem

  STRAND FROM GAUZE CAME OFF DURING USE AND HAD TO BE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17641466 ↗