HALYARD SGL90080Recalls & reported problems
Ansell Healthcare Product · HALYARD Polyisoprene Micro Size 8, Sterile Polyisoprene Powder-Free Surgical Glove · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651483208), received between Jul 28, 2023 and Aug 16, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (2 reports).
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/Hole2
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.
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. INCIDENT IS POTENTIALLY CAUSED BY A PUNCTURE OF SOME KIND. ADDITIONAL DETAILS REGARDING INCIDENT WAS ASKED OF REPORTER ON JULY 20 AND AUGUST 10, 2023. NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17557571 ↗MalfunctionJul 28, 2023Material Puncture/Hole; Material Puncture/Hole
AN INCIDENT OCCURRED USING THE GLOVES DURING USE WITH A PATIENT. THERE WAS NO MEDICAL INTERVENTION/INJURY THAT OCCURRED ON THE PART OF THE USER OR THE PATIENT. THIS INCIDENT CAUSED A BREACH IN STERILITY. PROVIDED THE HOLE WAS DISCOVERED DURING PROCEDURE, THE SITE HAS EVALUATED THAT THIS INCIDENT COULD CAUSE A SERIOUS INJURY OR ILLNESS SHOULD IT RECUR DURING A SURGICAL PROCEDURE AND IS THEREFORE BEING REPORTED AS A MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17419218 ↗
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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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