HALYARD SGL94080Recalls & reported problems
Ansell Healthcare Product · HALYARD Polyisoprene Neoprene Hybrid Size 8, Sterile Powder-Free Surgical Glove, Polyisoprene and Neoprene Blend · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651483291), received between Aug 16, 2023 and Aug 16, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).
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 16, 2026.
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.
MalfunctionAug 16, 2023Material Puncture/Hole; Material Puncture/Hole
BOTH GLOVES RIPPED MID-CASE DURING USE. IT APPEARS TO BE A TEAR THE SIZE OF A PINHOLE. THE INCIDENT APPEARS TO BE POTENTIALLY CAUSED BY A PUNCTURE OF SOME KIND. ADDITIONAL INCIDENT DETAILS HAVE BEEN REQUESTED ON JULY 24 AND AUGUST 9TH, 2023. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO-DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17558001 ↗
Other Surgeon'S Gloves devices
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- Medline Industries, Inc. DYNJ63673DMedline Industries, Inc. · Surgeon's gloves1 recall1 report
- GAMMEX 20685265Ansell Healthcare Product · Surgeon'S Gloves1 recall1 report
- NOVAPLUS V20685275Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- GAMMEX 20685290Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- NOVAPLUS V20685280Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- PROTEXIS 2D72PL65XCardinal Health 200, LLC · 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
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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