CONVERTORSRecalls & reported problems across all models
Cardinal Health 200, LLC · 38 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
11 open recalls name at least one CONVERTORS model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 40
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls
- 11
We found 38 models of CONVERTORS by Cardinal Health 200, LLC in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Nov 8, 2016 and Dec 7, 2021 — classified as 26 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (7 reports).
11 FDA recall records name at least one of these models by its device identifier, 11 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
CONVERTORS 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.
- Nov 2, 2021Open, Classified
Potential for open packaging seals compromising the sterility of the surgical gowns
Z-0378-2022 · Root cause: Process control · Recall details · FDA record ↗
- Nov 2, 2021Open, Classified
Potential for open packaging seals compromising the sterility of the surgical gowns
Z-0377-2022 · Root cause: Process control · Recall details · FDA record ↗
- Nov 2, 2021Open, Classified
Potential for open packaging seals compromising the sterility of the surgical gowns
Z-0376-2022 · Root cause: Process control · Recall details · FDA record ↗
- Nov 2, 2021Open, Classified
Potential for open packaging seals compromising the sterility of the surgical gowns
Z-0375-2022 · Root cause: Process control · Recall details · FDA record ↗
- Nov 2, 2021Open, Classified
Potential for open packaging seals compromising the sterility of the surgical gowns
Z-0374-2022 · Root cause: Process control · Recall details · FDA record ↗
- Nov 2, 2021Open, Classified
Potential for open packaging seals compromising the sterility of the surgical gowns
Z-0373-2022 · Root cause: Process control · Recall details · FDA record ↗
- Nov 2, 2021Open, Classified
Potential for open packaging seals compromising the sterility of the surgical gowns
Z-0372-2022 · Root cause: Process control · Recall details · FDA record ↗
- Nov 2, 2021Open, Classified
Potential for open packaging seals compromising the sterility of the surgical gowns
Z-0371-2022 · Root cause: Process control · Recall details · FDA record ↗
- Nov 2, 2021Open, Classified
Potential for open packaging seals compromising the sterility of the surgical gowns
Z-0370-2022 · Root cause: Process control · Recall details · FDA record ↗
- Nov 2, 2021Open, Classified
Potential for open packaging seals compromising the sterility of the surgical gowns
Z-0369-2022 · Root cause: Process control · Recall details · FDA record ↗
- Nov 2, 2021Open, Classified
Potential for open packaging seals compromising the sterility of the surgical gowns
Z-0368-2022 · Root cause: Process control · Recall details · FDA record ↗
Most reported CONVERTORS problems
Device problems
- Adverse Event Without Identified Device or Use Problem12
- Patient-Device Incompatibility7
- Material Split, Cut or Torn4
- Material Puncture/Hole3
- Contamination /Decontamination Problem2
- Device Contamination with Chemical or Other Material2
- Insufficient Device Problem Information2
- Contamination1
Patient problems
- No Known Impact Or Consequence To Patient9
- Hypersensitivity/Allergic reaction6
- Rash6
- No Clinical Signs, Symptoms or Conditions4
- Swelling4
- Exposure to Body Fluids3
- Erythema2
- Reaction2
CONVERTORS models
38 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CONVERTORS 9070GOWN, SURGICAL1 recall0 reports
- CONVERTORS 9518GOWN, SURGICAL1 recall0 reports
- CONVERTORS 9548GOWN, SURGICAL1 recall0 reports
- CONVERTORS 9578GOWN, SURGICAL1 recall0 reports
- CONVERTORS 95998GOWN, SURGICAL1 recall0 reports
- CONVERTORS 32474Gown, Surgical1 recall0 reports
- CONVERTORS 9010GOWN, SURGICAL1 recall0 reports
- CONVERTORS 9040GOWN, SURGICAL1 recall0 reports
- CONVERTORS 9041ELGeneral surgery tray1 recall0 reports
- CONVERTORS 9041General surgery tray1 recall0 reports
- CONVERTORS 9011General surgery tray1 recall0 reports
- CONVERTORS AT70021Mask, surgical5 reports
- CONVERTORS 39049GOWN, SURGICAL3 reports
- CONVERTORS 9575GOWN, SURGICAL3 reports
- CONVERTORS AT73335Mask, surgical3 reports
- CONVERTORS AT74531Mask, surgical3 reports
- CONVERTORS 9157Drape, surgical, exempt2 reports
- CONVERTORS 39099GOWN, SURGICAL1 report
- CONVERTORS 9545ELAGOWN, SURGICAL1 report
- CONVERTORS 29480General surgery tray1 report
- CONVERTORS 39079GOWN, SURGICAL1 report
- CONVERTORS D1061Drape, patient, ophthalmic1 report
- CONVERTORS 9349Drape, surgical, exempt1 report
- CONVERTORS 9071ELGOWN, SURGICAL1 report
- CONVERTORS 29242General surgery tray (kit)1 report
- CONVERTORS 8378Drape, surgical, exempt1 report
- CONVERTORS 32474GOWN, SURGICAL1 report
- CONVERTORS 29367General surgery tray1 report
- CONVERTORS 9515GOWN, SURGICAL1 report
- CONVERTORS 9041GOWN, SURGICAL1 report
- CONVERTORS 9011GOWN, SURGICAL1 report
- CONVERTORS AT71021Mask, surgical1 report
- CONVERTORS AT73035Mask, surgical1 report
- CONVERTORS AT51334Mask, surgical1 report
- CONVERTORS AT74535Mask, surgical1 report
- CONVERTORS AT74635-IMask, surgical1 report
- CONVERTORS 89015NGOWN, SURGICAL1 report
- CONVERTORS 39045NAGOWN, SURGICAL1 report
Recent CONVERTORS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN INCIDENT WAS REPORTED FOR AN ASSOCIATE THAT EXPERIENCED AN ALLERGIC REACTION TO A CARDINAL HEALTH MASK. THE TEAM MEMBER HAD TO BE PRESCRIBED A 7-DAY TREATMENT OF PREDNISONE TO TREAT SEVERE DERMATITIS. WE HAVE NOT RECEIVED ANY ADDITIONAL FOLLOW UP AFTER SEVERAL REQUESTS.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 12956663 ↗MalfunctionNov 19, 2021Contamination
PATIENT WITH HISTORY OF BLADDER RUMOR, HEMATURIA, ELEVATED PROSTATE-SPECIFIC ANTIGEN (PSA) AND HYDRONEPHROSIS WAS ADMITTED FOR A TRANSRECTAL ULTRASOUND GUIDED PROSTATE BIOPSY, CYSTOSCOPY AND RETROGRADE PYELOGRAMS AND RIGHT URETERAL STENT INSERTION TRANSURETHRAL RESECTION OF BLADDER TUMOR. WHEN THE CYSTOSCOPY PACK WAS OPENED, THERE WAS A FOREIGN BODY PRESENT. CYSTOSCOPY PACK WAS NOT USED AND A NEW ONE WAS OBTAINED FOR THE PROCEDURE. UNFORTUNATELY, THE FOREIGN BODY INSIDE THE PACK. WAS NOT SAVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12843337 ↗InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT REPORTED THROUGH MEDWATCH REPORT #MW5103107 THAT THEY RECEIVED CHEMICAL BURNS/RASH AFTER WEARING A CARDINAL HEALTH LEVEL 1 PROCEDURE MASK. ACCORDING TO REPORT, THEIR FACE BEGAN TO STING AND PEEL. THEY ALSO HAD CHEMICAL BURNS ON THEIR NOSE, INNER EYE, AND CHEEK AREA FROM THE MASK. NO FURTHER INFORMATION WAS PROVIDED AFTER MULTIPLE ATTEMPTS TO REACH CUSTOMER.
Patient problems: Caustic/Chemical Burns; Rash
MAUDE report 12641046 ↗MalfunctionAug 19, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
CUSTOMER REPORTED DURING PROCEDURE THERE WAS A TEAR IN THE SURGICAL TECH¿S GOWN. SLEEVE TEAR WAS FOUND DURING PROCEDURE. NO TREATMENT WAS REQUIRED FOR THE SURGICAL TECH. ADDITIONAL ANTIBIOTICS WERE ADMINISTERED TO THE PATIENT PROPHYLACTICALLY. THE SURGEON GAVE THE PATIENT KEFLEX IRRIGATION BECAUSE OF THIS INCIDENT DUE TO POSSIBLE CONTAMINATION IN ADDITION TO THE CEFAZOLIN THEY RECEIVED FROM ANESTHESIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12342394 ↗MalfunctionMay 18, 2021Delivered as Unsterile Product; Physical Resistance/Sticking
WHILE OPENING TO THE BACK SURGICAL TABLE, SCRUB TECH NOTICED THAT THE OUTSIDE PACKAGING, OF THE CONVERTORS GENERAL PURPOSE STERILE THREE-QUARTER DRAPE, WAS STUCK TO THE INSIDE STERILE WRAPPING. AS IT WAS OPENED, IT RIPPED THE INSIDE WRAPPING MAKING IT NO LONGER STERILE.
Patient problems: Insufficient Information
MAUDE report 11841001 ↗InjuryApr 9, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
CUSTOMER REPORTED THE DRAPE IS THINNER IN ALL AREAS. DURING AN OPEN HEART PROCEDURE WHEN TRYING TO OPEN THE VELCRO IN THE POCKETS, THE VELCRO STAYED CLOSED AND TORE THE DRAPE. CUSTOMER STATED NON-PERFORATING INSTRUMENTS THAT SECURE TUBING TO THE DRAPE TORE THE DRAPE AND SEPARATED THE LAYERS AND THE WEIGHT OF ONE SURGICAL INSTRUMENT IS ENOUGH TO SHRED THE DRAPE; ADD ONE LINE OF TUBING AND IT WILL FALL TO THE FLOOR. THE SURGEON HAD TO USE AN ANTIBIOTIC IRRIGATION FOR THE OPEN CHEST TO HOPEFULLY PREVENT STERNAL INFECTION. CUSTOMER COULD NOT DETERMINE WHICH THEY ADMINISTERED, EITHER KEFZOL 2GM OR VANCOMYCIN 1GM. NO FURTHER ISSUE TO PATIENT WAS REPORTED POST-OP. EVENT DATE UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11645731 ↗InjuryApr 5, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
CUSTOMER REPORTED THE DRAPE IS THINNER IN ALL AREAS. DURING AN OPEN HEART PROCEDURE WHEN TRYING TO OPEN THE VELCRO IN THE POCKETS, THE VELCRO STAYED CLOSED AND TORE THE DRAPE. CUSTOMER STATED NON-PERFORATING INSTRUMENTS THAT SECURE TUBING TO THE DRAPE TORE THE DRAPE AND SEPARATED THE LAYERS AND THE WEIGHT OF ONE SURGICAL INSTRUMENT IS ENOUGH TO SHRED THE DRAPE; ADD ONE LINE OF TUBING AND IT WILL FALL TO THE FLOOR. THE SURGEON HAD TO USE AN ANTIBIOTIC IRRIGATION FOR THE OPEN CHEST TO HOPEFULLY PREVENT STERNAL INFECTION. CUSTOMER COULD NOT DETERMINE WHICH THEY ADMINISTERED, EITHER KEFZOL 2GM OR VANCOMYCIN 1GM. NO DEMOGRAPHICS WERE PROVIDED. NO FURTHER ISSUE TO PATIENT WAS REPORTED POST-OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11616433 ↗InjuryJan 3, 2021Adverse Event Without Identified Device or Use Problem
BASED ON INFORMATION RECEIVED FROM THE CUSTOMER THEY ALLEGEDLY HAD AN ADVERSE REACTION TO GOWN 39099. PER CUSTOMER THE EVENT DATE WAS SOMETIME BETWEEN (B)(6) 2020, NOT AWARE OF REACTION UNTIL DAYS LATER. THEY WERE SEEN IN EMPLOYEE HEALTH, DERMATOLOGIST AND ALLERGIST. THEY WERE REPORTEDLY PRESCRIBED TOPICAL BETAMETHASONE.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 11105782 ↗InjurySep 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED A NURSE DEVELOPED REDNESS AND HIVES ON HER ARMS WHILE WEARING AAMI LEVEL 3 NON-REINFORECED SURGICAL GOWN XL 9545 REQUIRING AN INTRAMUSCULAR STEROID INJECTION AND ORAL BENADRYL. SHE HAS HISTORY OF ALLERGY TO FORMALDEHYDE. THE EVENT DATE IS UNKNOWN BY THE CUSTOMER. REPORT FILED FOR SERIOUS INJURY.
Patient problems: Erythema; Skin Irritation
MAUDE report 10549976 ↗InjurySep 16, 2020Patient-Device Incompatibility
CONSUMER REPORTED ALLERGIC REACTIONS TO THE MASK AND HISTORY OF ALLERGIES. SHE REPORTS NEVER HAVING TO WEAR A SURGICAL MASK BEFORE, BUT NOW WEARS THE MASK FOR AT LEAST 12 HOURS DURING HER WORK DAY AND IS HAVING BREATHING PROBLEMS SUCH AS COUGHING, ASTHMA-LIKE SYMPTOMS. SHE IS THE ONLY ONE HAVING AN ALLERGIC REACTION.
Patient problems: Dyspnea; Hypersensitivity/Allergic reaction
MAUDE report 10540622 ↗MalfunctionJul 28, 2020Contamination /Decontamination Problem
THE OPERATING ROOM TECH FOUND A DEAD BUG WHEN OPENING A CARDINAL HEALTH 200 CONVERTORS TABLE COVER FOR A TOTAL KNEE ARTHROPLASTY. THE CONTAMINATED TABLE COVER WAS IMMEDIATELY DISCHARGED FROM THE OR AND A NEW DEVICE WAS OPENED TO CONTINUE THE ORIGINAL INTENDED PROCEDURE. NOTHING ELSE WAS CONTAMINATED DURING THE INCIDENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10331830 ↗MalfunctionJul 23, 2020Therapeutic or Diagnostic Output Failure
CUSTOMER REPORTED STRIKETHROUGH OF GOWN TO PHYSICIAN¿S ARMS DURING A DIAGNOSTIC LAPAROSCOPY AND LAPAROTOMY ADHESIOLYSIS W/ LAVAGE CHOLECYSTECTOMY FOR PERFORATED GALLBLADDER. THERE WAS NO REPORTED INJURY TO PHYSICIAN OR PATIENT DUE TO STRIKETHROUGH. IT WAS REPORTED THAT MEROPENEM 1G IN .09% SODIUM CHLORIDE 50ML MBP WAS GIVEN TO THE PATIENT AT THE BEGINNING OF THE SURGERY FOR THE PERFORATED GALLBLADDER INFECTION RISK SO NO ADDITIONAL ANTIBIOTICS WERE LATER NEEDED DUE TO THE STRIKETHROUGH. NO DEMOGRAPHICS PROVIDED. MDR BEING FILED FOR POTENTIAL RISK TO PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10318181 ↗MalfunctionJul 8, 2020Material Puncture/Hole
SURGICAL SMARTGOWN WAS DONNED IN PREPARATION FOR SURGERY. AFTER ARMS WERE IN THE GOWN AND BEFORE PICKING UP GLOVES, A LARGE HOLE WAS FOUND ALONG A SEEM ON THE LEFT SLEEVE NEAR THE WRIST. THE GOWN WAS REMOVED AND SAVED FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10244585 ↗InjuryMay 31, 2020Adverse Event Without Identified Device or Use Problem
EMPLOYEE IN IMAGING SERVICES REPORTED DEVELOPING SKIN IRRITATION/RASH AFTER WEARING MASK. EMPLOYEE HAS A LATEX ALLERGY. SHE WENT TO THE EMERGENCY DEPARTMENT WITH EYE SWELLING AND WAS GIVEN ORAL PREDNISONE. EMPLOYEE FINISHED PREDNISONE DOSE PACK AND REPORTS SHE IS DOING FINE NOW.
Patient problems: Rash
MAUDE report 10103897 ↗MalfunctionMar 26, 2020Material Puncture/Hole; Failure to Align
THE PHYSICIAN'S GOWN WAS NOTED TO BE MISALIGNED AT THE SEAMS CREATING HOLES IN THE STERILE GOWN. OPERATION ROOM TEAM MEMBERS COVERED IT WITH A TEGADERM AND KEPT WORKING. THE INTEGRITY OF PAPER GOWNS IS BEING CALLED INTO QUESTION WITH MULTIPLE ISSUES AND RECALLS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9882725 ↗
Other Cardinal Health 200, LLC products
- JACKSON-PRATT20 models · 13 reports · 19 recalls
- Monoject35 models · 96 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
- NOVAPLUS7 models · 75 reports · 1 recall
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.
How reports and recalls are matched · Editorial policy · Report an error on this page