GAMMEXRecalls & reported problems across all models
Ansell Healthcare Product · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one GAMMEX model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 8 models of GAMMEX by Ansell Healthcare Product in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Dec 21, 2023 and Dec 21, 2023 — classified as 1 malfunction.
2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
GAMMEX recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 3, 2023Open, Classified
Some surgical glove sterile pouches were not completely sealed.
Z-0096-2024 · Root cause: Process control · names 8 of these models · Recall details · FDA record ↗
- Feb 19, 2022Open, Classified
Transport company failed to stop at the border for required FDA inspection.
Z-0838-2022 · Root cause: Other · Recall details · FDA record ↗
Most reported GAMMEX problems
Patient problems
- No Clinical Signs, Symptoms or Conditions1
GAMMEX models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GAMMEX 20685275Surgeon'S Gloves2 recalls0 reports
- GAMMEX 20685265Surgeon'S Gloves1 recall1 report
- GAMMEX 20685255Surgeon'S Gloves1 recall0 reports
- GAMMEX 20685260Surgeon'S Gloves1 recall0 reports
- GAMMEX 20685270Surgeon'S Gloves1 recall0 reports
- GAMMEX 20685280Surgeon'S Gloves1 recall0 reports
- GAMMEX 20685285Surgeon'S Gloves1 recall0 reports
- GAMMEX 20685290Surgeon'S Gloves1 recall0 reports
Recent GAMMEX adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 21, 2023
THE FINGERTIPS WERE DEFECTIVE AND THERE WAS A HOLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18371164 ↗
Other Ansell Healthcare Product products
All Ansell Healthcare Product devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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