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Medline Industries, Inc. DYNJ909132FRecalls & reported problems

Medline Industries, Inc. · SET UP · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Medline general surgery tray kit has no adverse event reports that name its identifier. It is named in 1 open recall from October 2025 after complaints of leaks from cracks in the kit's expandable anesthesia tubing.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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 10, 2025Class IOpen, Classified

    Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

    Z-0448-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Other General surgery tray devices

All General surgery tray devices →

Sources and updates

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