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Medline Industries, Inc. DYNJS0703Recalls & reported problems

Medline Industries, Inc. · ENT II-LF · Class 1

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

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10080196597529), received between Aug 13, 2026 and Aug 13, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unsealed Device Packaging” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Mar 19, 2026Class IIOpen, Classified

    During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

    Z-2021-2026 · 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-1072-2023 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Device problems

  • Unsealed Device Packaging1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionAug 13, 2026Unsealed Device Packaging

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50240298 ↗

Other Ear, nose, and throat surgical tray devices

All Ear, nose, and throat surgical tray devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page