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Medline Industries, Inc. DYNJS3032Recalls & reported problems

Medline Industries, Inc. · MAJOR SINGLE BASIN W/GOWNS · Class 2

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
2
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884389408407), received between Oct 4, 2023 and Sep 22, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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-1441-2025 · 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-1074-2023 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Device problems

  • Break1
  • Device Markings/Labelling Problem1
  • Material Puncture/Hole1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 22, 2026Material Puncture/Hole; Device Markings/Labelling Problem

    It was reported that "The first picture has a pack that was not sealed correctly. The second picture is of a hole in the pack that did not have a hole in the wrapper."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50856067 ↗
  • MalfunctionOct 4, 2023Break; Break

    BLADE BROKE DURING PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17869903 ↗

Other laparoscopy kit devices

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Sources and updates

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