Medline Industries, Inc. DYNJ63673DRecalls & reported problems
Medline Industries, Inc. · GLOVE PACK 7.0 (15PK) · Class 1
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.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10195327304843), received between Apr 29, 2026 and Apr 29, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (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.
Reports received per month
Recalls naming this device
- Feb 27, 2026Class IOpen, Classified
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Z-1725-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Puncture/Hole1
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.
MalfunctionApr 29, 2026Material Puncture/Hole
IT WAS REPORTED THAT THE STERILE GLOVES TEAR EASILY DURING DONNING. ADDITIONALLY, THE GLOVES WERE REPORTED TO ROLL DOWN AT THE WRIST, ALLOWING FLUID TO BREACH THE BARRIER AND ENTER THE INTERIOR OF THE GLOVE, RESULTING IN A POTENTIAL RISK OF CONTAMINATION. THIS ISSUE WAS REPORTED TO OCCUR CONSISTENTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25029025 ↗
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- GAMMEX 20685290Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- NOVAPLUS V20685290Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
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.
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