PROTEXISRecalls & reported problems across all models

We found 17 models of PROTEXIS by Cardinal Health 200, LLC in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Sep 19, 2017 and Aug 10, 2026 — classified as 8 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Separation” (12 reports).

1 FDA recall record name at least one of these models by its device identifier.

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

PROTEXIS 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.

1. Mar 15, 2022Completed

   Product was distributed without being sterilized.

   Z-0902-2022 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

Most reported PROTEXIS problems

PROTEXIS models

17 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PROTEXIS 2D72PT65X

  Surgeon's gloves
  1 recall2 reports
• PROTEXIS 2D72PL65X

  Surgeon's gloves
  1 recall0 reports
• PROTEXIS 2D73TE70

  Surgeon's gloves
  3 reports
• PROTEXIS 2D73PM60

  Surgeon's gloves
  3 reports
• PROTEXIS 2D73PM55

  Surgeon's gloves
  2 reports
• PROTEXIS 2D73PM65

  Surgeon's gloves
  2 reports
• PROTEXIS 2D73EB80

  Surgeon's gloves
  2 reports
• PROTEXIS 2D72PL70X

  Surgeon's gloves
  2 reports
• PROTEXIS 2D72PL75X

  Surgeon's gloves
  2 reports
• PROTEXIS 2D72LS75

  Surgeon's gloves
  1 report
• PROTEXIS 2D73PM70

  Surgeon's gloves
  1 report
• PROTEXIS 2D73PM75

  Surgeon's gloves
  1 report
• PROTEXIS 2D73EB60

  Surgeon's gloves
  1 report
• PROTEXIS 2D72NT70X

  Surgeon's gloves
  1 report
• PROTEXIS 2D72NT80X

  Surgeon's gloves
  1 report
• PROTEXIS 2D72PT75X

  Surgeon's gloves
  1 report
• PROTEXIS 2D72PT80X

  Surgeon's gloves
  1 report

Recent PROTEXIS adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Material Split, Cut or Torn

  Infusion RN working in Infusion Lab reports that the sterile gloves we currently have in stock seem to be more fragile. 4 out of 5 pair have torn very easily this am.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50191960 ↗
• InjuryJul 2, 2026Material Separation

  A CUSTOMER REPORTED THAT THERE HAD BEEN AN ISSUE IN THE THEATRE ON (B)(6) 2026. THE SURGEON HAD JUST CUT INTO THE PATIENT TO INSERT SCOPE (LAPARSCOPICALLY). THE SURGEON HAD USED A CARDINAL GLOVE, AND THE GLOVE WAS REPORTED TO FEEL STICKY WHEN WET. THE SURGEON HAD BEEN HANDLING THE SCOPE, AND THE GLOVE HAD STUCK TO THE SCOPE. THE SURGEON HAD MOVED HIS HAND, AND THE GLOVE RIPPED RESULTING IN A SMALL PIECE OF GLOVE FALLING INTO PATIENT¿S ABDOMEN. IT HAD NOT BEEN RECOVERED DESPITE EXTENSIVE SEARCHING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25698484 ↗
• MalfunctionMar 5, 2026Material Separation

  CUSTOMER REPORTED THAT THERE WAS A TEAR ON THE LEFT PALM OF THE GLOVE, AND REMNANTS OF THE TORN MATERIAL WERE PRESENT. ADDITIONAL INFORMATION WAS RECEIVED AND A PHOTO SHOWED GLOVE SPLIT INTO 2 PIECES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523810 ↗
• MalfunctionJan 12, 2026Material Separation

  CUSTOMER REPORTED THAT THERE WAS A PINHOLE IN THE RIGHT MIDDLE FINGER AREA SO THE GLOVES BROKE INTO TWO PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048056 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 1, 2025Material Separation; Material Separation

  CUSTOMER REPORTED A TEAR INTO TWO PIECES AT THE CUFF ON ONE GLOVE AND AT THE BASE OF THE PALM ON THE LEFT GLOVE DURING DONNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687527 ↗
• MalfunctionDec 1, 2025Material Separation; Material Separation

  CUSTOMER REPORTED THAT THE GLOVE HAD A LEFT TEAR INTO TWO PIECES AT THE BASE OF THE PALM DURING DONNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23684586 ↗
• MalfunctionNov 21, 2025Material Separation; Material Separation

  CUSTOMER REPORTED THAT THE GLOVE HAS TORN APART ON LEFT BASE OF PALM DURING DONNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622839 ↗
• MalfunctionAug 21, 2025Material Separation; Material Separation

  CUSTOMER REPORTED THAT THE TIP OF THE LITTLE FINGER OF THE LEFT GLOVE WAS TORN. THE MISSING PIECE WAS NOT THERE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22866243 ↗
• MalfunctionMay 30, 2025Material Separation; Material Separation

  CUSTOMER REPORTED A HOLE IN GLOVE; SPLIT INTO TWO PIECES. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22119245 ↗
• MalfunctionApr 24, 2025Material Separation; Material Separation

  CUSTOMER REPORTED THAT PER THE SURGEON, ONE GLOVE TORE APART AND MADE A HOLE WHEN PUT ON. ANOTHER PAIR TORE INTO TWO PIECES WHERE THE ROLLED EDGE TORE OFF COMPLETELY BUT THIS WAS NOT DOCUMENTED AND THERE WAS NO SAMPLE OR PHOTO OF THIS. IT COULD BE SEEN AT THE BREAK POINT THAT THE RUBBER WAS THINNER. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903940 ↗
• InjuryJul 17, 2023Material Puncture/Hole; Material Puncture/Hole

  CUSTOMER STATED A SURGICAL GLOVE BREACH OCCURRED DURING C-SECTION DELIVERY. SURGEON WAS FOUND TO HAVE A HOLE IN HER GLOVE DURING PROCEDURE. THE HOLE WAS NOTICED AFTER THE UTERUS AND FASCIA WERE CLOSED. SURGEON CONCERNED THAT PIECE OF GLOVE COULD HAVE BEEN LEFT INSIDE THE PATIENT. AS A PRECAUTION THE SURGEON OPENED THE ABDOMEN AND UTERUS BACK UP AND PERFORMED AN EXPLORATION AND IRRIGATION TO SEE IF SHE COULD FIND ANY PIECE OF THE GLOVE. NO PIECE OF A GLOVE WAS FOUND. THE PATIENT WAS PRESCRIBED IV ANCEF WHILE SHE WAS ADMITTED TO THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17337353 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING PLACEMENT OF AN IMPLANTABLE CATHETER FOR CHEMOTHERAPY, IT WAS REPORTED THAT FROM THE CLINICIAN¿S STERILE NITRILE GLOVES, THE PATIENT DEVELOPED A SENSATION OF GENERALIZED PRURITUS, GENERALIZED RASH WITH APPEARANCE OF HIVES, FEELING OF DYSPNEA, DIZZINESS WITH TENDENCY TO WORSEN. PATIENT WAS SENT TO THE EMERGENCY ROOM FOR MONITORING OF CONDITION AND ANAPHYLAXIS. PATIENT REQUIRED 02 THERAPY TO RAISE SATURATION FROM 85-87% TO 94%. 40MG OF DEFIDRAMINE IV AND 100MG OF HYDROCORTISONE WERE ADMINISTERED TO THE PATIENT. THE PATIENT WAS REPORTED AS STABLE AFTER TREATMENT.

  Patient problems: Anaphylactic Shock

  MAUDE report 15299257 ↗

Other Cardinal Health 200, LLC products

• JACKSON-PRATT20 models · 13 reports · 19 recalls
• Monoject35 models · 96 reports · 11 recalls
• CONVERTORS38 models · 40 reports · 11 recalls
• Argyle33 models · 58 reports · 7 recalls
• Salem Sump31 models · 40 reports · 7 recalls
• Dover45 models · 241 reports · 2 recalls
• Kendall31 models · 51 reports · 3 recalls
• Kangaroo35 models · 130 reports