FLEXAL 88TN04LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20885380137133), received between Apr 5, 2018 and Jul 30, 2025 — classified as 2 injuries, 1 malfunction.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2025Material Puncture/Hole

  I NOTICED A HOLE IN A GLOVE AFTER I PUT IT ON. SIZE LARGE. LOT MY37AA5B023. MFG DATE 2025-02-01. GLOVE BOX REMOVED FROM SERVICE. MANUFACTURER RESPONSE FOR POLYMER PATIENT EXAMINATION GLOVE, FLEXAL (PER SITE REPORTER). NONE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666884 ↗
• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED A 45 YEAR OLD FEMALE STAFF MEMBER WAS PREPPING THE PATIENT FOR A VEIN ABLATION. THEY PUT ON THE SAME NITRILE GLOVES THEY'VE BEEN USING FOR YEARS AND WITHIN A MINUTE OF HAVING THE GLOVES ON, THEIR PALMS BEGAN TO ITCH. THEY REMOVED THE GLOVES AND WASHED THEIR HANDS, THEN SHORTLY AFTERWARDS THEIR HANDS STARTED TURNING RED AND SWELLING. AROUND 3 MINUTES LATER, THEIR CHEST STARTED TO GET A RASH. 5 MINUTES IN, THEIR TONGUE AND THROAT BEGAN TO SWELL TO THE POINT THAT THEY WERE UNABLE TO SWALLOW. THE STAFF MEMBER WAS TAKEN TO THE EMERGENCY ROOM AT PIEDMONT FAYETTE, WHERE THE EMERGENCY DEPARTMENT ADMINISTERED TWO ROUNDS OF EPI, AND THEY RECEIVED BENADRYL VIA IV FLUIDS. THEY WERE MONITORED IN THE EMERGENCY DEPARTMENT FOR 4-5 HOURS AND WAS SUBSEQUENTLY DISCHARGED AND WAS SENT HOME WITH PREDNISONE 20MG TO BE TAKEN FOR 1 WEEK. THE STAFF MEMBER ADVISED THEY ARE 95% SURE THAT THE PRODUCT THAT CAUSED THE ADVERSE REACTION WAS FLEXAL GLOVE NITRILE FROM CARDINAL HEALTH. THEY ADDITIONALLY STATED THAT THEIR FACILITY IS LATEX FREE AND THERE ARE NO LATEX PRODUCTS ON SITE.

  Patient problems: Anaphylactic Shock

  MAUDE report 19554534 ↗
• InjuryApr 5, 2018Patient-Device Incompatibility

  HOUSEKEEPER REPORTS THAT THE GLOVES HAVE CAUSED HER HANDS TO BREAK OUT. THE PALMS OF HER HANDS HAVE TURNED YELLOW, HER KNUCKLES AND FINGERS HAVE TURNED DARKER AND SHE HAS CUTS ON HER HANDS AS WELL AS SORES IN BETWEEN HER FINGERS AND AT THE KNUCKLES. SHE SAW A DERMATOLOGIST AND A PHYSICIAN.

  Patient problems: Hypersensitivity/Allergic reaction; Skin Discoloration; Skin Irritation

  MAUDE report 7399288 ↗