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
Recalls naming this device
- 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 ↗
- 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
- Medline Industries, Inc. DYNJ82871Medline Industries, Inc. · laparoscopy kit5 recalls0 reports
- Medline Industries, Inc. CDS860015WMedline Industries, Inc. · laparoscopy kit4 recalls0 reports
- Medline Industries, Inc. CDS860016RMedline Industries, Inc. · laparoscopy kit4 recalls0 reports
- Medline Industries, Inc. DYNJ0426069NMedline Industries, Inc. · laparoscopy kit4 recalls0 reports
- Medline Industries, Inc. DYNJ905071FMedline Industries, Inc. · laparoscopy kit4 recalls0 reports
- Medline Industries, Inc. DYNJ52656BMedline Industries, Inc. · laparoscopy kit4 recalls0 reports
- Medline Industries, Inc. DYNJ21927RMedline Industries, Inc. · laparoscopy kit4 recalls0 reports
- Medline Industries, Inc. DYNJ58561DMedline Industries, Inc. · laparoscopy kit3 recalls1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page