PROTEXIS 2D73PM60Recalls & reported problems
Cardinal Health 200, LLC · Sterile Polyisoprene Powder-Free Surgical Gloves · Class 1
All models of PROTEXIS (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885380027260), received between May 13, 2019 and Jan 12, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.
Reports received per month
Most reported problems
Device problems
- Patient-Device Incompatibility2
- Material Separation1
Patient problems
- Irritation2
- Hypersensitivity/Allergic reaction1
- Itching Sensation1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 12, 2026Material Separation
CUSTOMER REPORTED THERE WERE FRAGMENTS CAUSED BY A TEAR IN THE RIGHT GLOVE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24047713 ↗InjuryMay 13, 2019Patient-Device Incompatibility
HEALTHCARE ASSISTANT INITIALLY DEVELOPED IRRITATION ON BACKS OF HANDS, FOLLOWED BY BLISTERING OF FINGERS AND PALMS OF HANDS. HANDS AND FINGER TIPS DEVELOPED DEEP CRACKS, AND IRRITATION SPREAD ALONG FOREARMS; HE ALSO HAD SIGNIFICANT PAIN. HE WAS SEEN INITIALLY BY A GP AND PRESCRIBED STEROID CREAMS. HE WAS ALSO SEEN BY OCCUPATIONAL HEALTH AND REFERRED FOR A DERMATOLOGY CONSULTATION AND SKIN TESTS WHICH SHOWED AN ALLERGY TO CARBAMIX AND AN ACCELERATOR. SIX WEEKS WERE REQUIRED TO HEAL. HE CURRENTLY NEEDS TO WEAR COTTON GLOVES UNDER ALL GLOVES.
Patient problems: Irritation; Pain
MAUDE report 8604862 ↗InjuryMay 13, 2019Patient-Device Incompatibility
NURSE EXPERIENCED IRRITATION TO DORSUM OF BOTH HANDS-ITCHY AND SORE. BLISTERING TO FINGERS AND AROUND NAIL BEDS. IRRITATION TO WRISTS AND FOREARMS. SHE WAS SEEN BY A GP WHO PRESCRIBED SEVERAL DIFFERENT CREAMS. SHE WAS ALSO SEEN BY OCCUPATIONAL HEALTH AND IS AWAITING A DERMATOLOGY APPOINTMENT AND ALLERGY TESTING.
Patient problems: Hypersensitivity/Allergic reaction; Irritation; Itching Sensation
MAUDE report 8603669 ↗
Other Surgeon's gloves devices
- GAMMEX 20685275Ansell Healthcare Product · Surgeon'S Gloves2 recalls0 reports
- PROTEXIS 2D72PT65XCardinal Health 200, LLC · Surgeon's gloves1 recall2 reports
- 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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