PROTEXIS 2D73PM55Recalls & reported problems
Cardinal Health 200, LLC · Sterile Polyisoprene Powder-Free Surgical Gloves · Class 1
Data updated Oct 13, 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 10885380027253), received between Jan 7, 2026 and Jan 9, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation2
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.
MalfunctionJan 9, 2026Material Separation
CUSTOMER REPORTED THERE WERE FRAGMENTS CAUSED BY THE TEAR IN THE LEFT GLOVE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24030462 ↗MalfunctionJan 7, 2026Material Separation
CUSTOMER REPORTED THE GLOVE IS EASILY TORN, AND WHEN TORN, FRAGMENTS FROM THE DAMAGED AREA FALL ONTO THE SURROUNDING AREA AND THE SURGICAL FIELD (RIGHT GLOVE). THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23998348 ↗
Other Surgeon's gloves devices
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- GAMMEX 20685265Ansell Healthcare Product · Surgeon'S Gloves1 recall1 report
- Medline Industries, Inc. DYNJ63673DMedline Industries, Inc. · Surgeon's gloves1 recall1 report
- GAMMEX 20685255Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- NOVAPLUS V20685265Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- NOVAPLUS V20685290Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- GAMMEX 20685260Ansell 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 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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