HALYARD SGL90065Recalls & reported problems
Ansell Healthcare Product · HALYARD Polyisoprene Micro Size 6.5, Sterile Polyisoprene Powder-Free Surgical Glove · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651483178), received between Jun 8, 2023 and Jun 8, 2023 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Puncture/Hole1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 8, 2023Material Puncture/Hole; Material Puncture/Hole
AN INCIDENT OCCURRED SEVERAL TIMES DURING DONNING OF THE GLOVES PRIOR TO USE AND AFTER USE WITH PATIENTS. THERE WAS NO MEDICAL INTERVENTION/INJURY OR EMPLOYEE HEALTH VISITS THAT OCCURRED ON THE PART OF THE USER OR PATIENT. THE HOLES WERE FOUND IN THE GLOVES NOT THE STERILE PACKAGING.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17088544 ↗
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- NOVAPLUS V20685265Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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