Medline Industries, Inc. DYNJ906444CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10195327362690), received between Sep 18, 2025 and Sep 18, 2025 — classified as 1 malfunction.

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

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. Dec 16, 2025Class IIOpen, Classified

   Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

   Z-1088-2026 · Root cause: Under Investigation by firm · 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.

• MalfunctionSep 18, 2025Temperature Problem; Temperature Problem

  ACCORDING TO THE FACILITY ON 08/21/2025 "THERE WAS VISIBLE SMOKE AND THE SMELL OF BURNING AS WELL AS THE BATTERY SECTION WAS HOT AND THE IRRIGATION TIP".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084766 ↗