KendallRecalls & reported problems across all models

We found 31 models of Kendall by Cardinal Health 200, LLC in the FDA's device registry (GUDID). Together they are named in 51 adverse event reports in the FDA's MAUDE database, received between Mar 23, 2021 and May 22, 2026 — classified as 14 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (14 reports).

3 FDA recall records 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

Kendall 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. May 13, 2025Class IICompleted

   Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.

   Z-1919-2025 · Root cause: Software change control · names 2 of these models · Recall details · FDA record ↗

2. May 13, 2025Class IICompleted

   Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.

   Z-1918-2025 · Root cause: Software change control · Recall details · FDA record ↗

3. May 13, 2025Class IICompleted

   Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.

   Z-1917-2025 · Root cause: Software change control · Recall details · FDA record ↗

Most reported Kendall problems

Kendall models

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

• Kendall 84021

  SLEEVE, LIMB, COMPRESSIBLE
  2 recalls0 reports
• Kendall 84021P

  SLEEVE, LIMB, COMPRESSIBLE
  1 recall0 reports
• Kendall 84021B

  SLEEVE, LIMB, COMPRESSIBLE
  1 recall0 reports
• Kendall 33507

  CABLE, ELECTRODE
  5 reports
• Kendall 31.1245.21

  Electrode, electrocardiograph
  5 reports
• Kendall 83022

  SLEEVE, LIMB, COMPRESSIBLE
  4 reports
• Kendall 33135T

  CABLE, ELECTRODE
  3 reports
• Kendall 33135T

  CABLE, ELECTRODE
  3 reports
• Kendall 31.1925.21

  Electrode, electrocardiograph
  3 reports
• Kendall 31319281

  Automated external defibrillators (non-wearable)
  3 reports
• Kendall 40000006

  Automated external defibrillators (non-wearable)
  3 reports
• Kendall 31479549

  Electrode, circular (spiral), scalp and applicator
  2 reports
• Kendall 31469219

  Automated external defibrillators (non-wearable)
  2 reports
• Kendall 33506

  CABLE, ELECTRODE
  1 report
• Kendall 33541

  CABLE, ELECTRODE
  1 report
• Kendall 33543

  CABLE, ELECTRODE
  1 report
• Kendall 33110

  CABLE, ELECTRODE
  1 report
• Kendall 33134

  CABLE, ELECTRODE
  1 report
• Kendall 33506

  CABLE, ELECTRODE
  1 report
• Kendall 222002

  Electrode, electrocardiograph
  1 report
• Kendall 22455

  Electrode, electrocardiograph
  1 report
• Kendall 22855

  Electrode, electrocardiograph
  1 report
• Kendall 22930

  Electrode, electrocardiograph
  1 report
• Kendall 30807732

  Electrode, electrocardiograph
  1 report
• Kendall 31.1355821

  Electrode, electrocardiograph
  1 report
• Kendall 31013926

  Electrode, electrocardiograph
  1 report
• Kendall 31043170

  Electrode, electrocardiograph
  1 report
• Kendall 31424743

  Electrode, electrocardiograph
  1 report
• Kendall 31424785

  Electrode, electrocardiograph
  1 report
• Kendall 31499224

  Electrode, Electrocardiograph
  1 report
• Kendall 33561

  CABLE, ELECTRODE
  1 report

Recent Kendall adverse event reports

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

• MalfunctionMay 22, 2026Incorrect Interpretation of Signal

  THE CUSTOMER REPORTED AN ISSUE WITH A SINGLE-USE LEAD SET THAT WAS BEING USED ON A PATIENT POST-OP DAY (POD) 5. THEY STATED THAT THE WAVEFORM WAS EASILY DISTINGUISHED AS NON-LETHAL. ADDITIONAL INFORMATION RECEIVED ON 05MAY2026 STATED THAT THE ERRONEOUS READING HAD HAPPENED SEVERAL TIMES OVER THE COURSE OF THE NIGHT FOR SHORT PERIODS. THE REPORTER WAS UNSURE IF IT ALARMED FOR VTACH. SHE STATED THAT IT IS QUITE POSSIBLE THAT THEY WERE ALARMING FOR VTACH AT ONE POINT OR ANOTHER, BUT THE LEADS WERE REPLACED BASED ON CLEARLY INACCURATE TRACINGS. IT WAS ALSO STATED THAT SINCE THEY WERE INTERMITTENTLY READING NORMAL SINUS RHYTHM, AND THE PATIENT WAS VERY CLEARLY NOT IN ANY DISTRESS, THEY DID NOT REQUIRE A FULL EKG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257451 ↗
• MalfunctionMay 22, 2026Fire

  THE CUSTOMER REPORTED A PATIENT INJURY OCCURRED AROUND 10:02AM ON (B)(6) 2026 WHEN USING CARDINAL HEALTH MATERIAL # 33134. IT WAS STATED THAT THE LEAD WIRE CAUGHT FIRE, AND DAMAGE HAPPENED TO PATIENT AND EQUIPMENT. THEY BELIEVE THE LOT NUMBER WAS K251013B BASED ON SUPPLY IN THE CLEAN UTILITY ROOM.

  Patient problems: Insufficient Information

  MAUDE report 25257350 ↗
• MalfunctionApr 30, 2026Incorrect Interpretation of Signal

  THE CUSTOMER REPORTED THAT THEY ENCOUNTERED AN ISSUE WITH A SET OF DISPOSABLE LEADS THE MORNING OF (B)(6) 2026. THEY STATED THAT THE DISPOSABLE LEADS WERE PERSISTENTLY ALARMING FOR VTACH, AND INTERMITTENTLY APPEARED TO BE A TRUE VTACH ON THE MONITOR. ACCOUNT REPOSITIONED THE LEADS WITH NO CHANGE. ON ACQUIRING A FORMAL EKG, THE PATIENT WAS IN CLEAR NORMAL SINUS RHYTHM. AFTER REPLACING THE ENTIRE LEAD SET (INCLUDING THE TRUNK CORD) THE RHYTHM ON THE MONITOR MATCHED THE NSR ON THE EKG. ECG READING IS ATTACHED. PER THE CUSTOMER ON (B)(6) 2026 THE PATIENT EXPERIENCED UNDUE ANXIETY AND THIS PULLED THE ENTIRE MEDICAL TEAM AWAY FROM OTHER ROUTINE CARE.

  Patient problems: Anxiety

  MAUDE report 25045217 ↗
• MalfunctionApr 27, 2026

  PATIENT'S ASSESSMENT IDENTIFIED LARGE AMOUNT OF BRUISING TO BILATERAL LEGS IN OUTLINE OF SCD [SEQUENTIAL COMPRESSION DEVICE] SLEEVES.

  Patient problems: Bruise/Contusion

  MAUDE report 24997927 ↗
• MalfunctionApr 23, 2026

  PATIENT REFUSED TO WEAR SEQUENTIAL COMPRESSION DEVICE (SCD) LEG SLEEVES DUE TO THEM BEING SCRATCHY, HOT/SWEATY AND UNCOMFORTABLE. NURSE REMOVED THE SCD LEG SLEEVES AND EDUCATED PATIENT TO AMBULATE WITH STAFF THROUGHOUT THE DAY FOR BLOOD CLOT PREVENTION.

  Patient problems: Diaphoresis; Discomfort; Hot Flashes/Flushes; Itching Sensation

  MAUDE report 24965341 ↗
• MalfunctionApr 23, 2026

  PATIENT REFUSED TO WEAR SEQUENTIAL COMPRESSION DEVICE (SCD) LEG SLEEVES BECAUSE IT MAKES HIM SWEAT AND CAUSES IRRITATION ON SHINS AND CALVES.

  Patient problems: Diaphoresis; Skin Inflammation/ Irritation

  MAUDE report 24965304 ↗
• MalfunctionApr 21, 2026

  SEQUENTIAL COMPRESSION DEVICE (SCD) LEG SLEEVES CAUSING INCREASED MOISTURE TO PATIENTS BILATERAL LOWER EXTREMITIES. SLEEVES BECOME VERY MOIST AND THEREFORE PATIENT'S SKIN BECOME MORE MOIST, NEEDING TO BE CHANGED DAILY TO PREVENT SKIN BREAKDOWN. MOISTURE ALSO CAUSING FOUL ODOR.

  Patient problems: Skin Disorders; Wound Odor

  MAUDE report 24937782 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THEY HAVE DEVELOPED A SEVERE ALLERGY TO THE ADHESIVE ELECTRODES USED DURING TREATMENT. THE PATIENT HAD AN EXTENSIVE RASH THAT STARTED IN THE MIDDLE OF THEIR FACE AND DESCENDED TO THEIR KNEES. THE AREA WAS BRIGHT RED AND THEY HAD AN INTENSE BURNING SENSATION ACCOMPANIED BY SEVERE ITCHING, TREMBLING AND CHILLS. NO PRODUCT WAS APPLIED BEFORE THE ELECTRODES. ABOUT 1/2 HOUR AFTER THE PLACEMENT OF THE ELECTRODES THE SKIN REACTION APPEARED WHILE THE ELECTRODES WERE STILL ON THEIR SKIN. THE FIRST TREATMENT WAS ORAL AND IT DIDN'T HELP KEEP THE REACTION FROM PROGRESSING. INTRAVENOUS CORTICOSTEROIDS WERE GIVEN AND THE PATIENT WAS UNDER OBSERVATION ON A HEART MONITOR AND BLOOD PRESSURE, LYING ON A STRETCHER. THE PATIENT HAD TO UNDERGO A SECOND INTRAVENOUS CORTICOSTEROIDS TREATMENT WHICH WORKED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24679862 ↗
• MalfunctionMar 11, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE NURSE NOTICED THAT THE LEADS WERE SHOWING A NORMAL SINUS RHYTHM (NSR) RHYTHM, BUT THE MONITOR WAS READING IT AS ASYSTOLE. SHE TRIED REPOSITIONING THE LEADS AND NOTHING WORKED. SHE REPLACED THE LEADS WITH A NEW SET AND THEY WERE FINE. ACCORDING TO THE CUSTOMER, THE ONLY THING THE REGISTERED NURSE (RN) CAN THINK OF WAS THAT SHE WAS GIVING A BED BATH WITH THE MEDLINE READY BATH WIPES JUST PRIOR TO THIS HAPPENING. BUT THE LEADS WERE NOT OVERLY SATURATED WITH FLUID. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24576057 ↗
• InjuryFeb 20, 2026Material Rupture

  A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION PRIMARY WITH MENTOR CE MED HGT TE W/SUT TABS 550CC, TISSUE EXPANDER EXPERIENCED LEFT SIDED DEFLATION POST OPERATION. THE ISSUE WAS DIAGNOSED THROUGH ULTRASOUND EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REPLACEMENT WITH SN (B)(6) ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24402426 ↗
• MalfunctionOct 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT WHEN THE ELECTRODE IS REMOVED FROM THE WIRE THAT IS CONNECTED TO THE HOLTER, THE BLACK TIP REMAINS IN THE PLUG AND MUST BE REMOVED BY REMOVING IT WITH A CHISEL OR PAPER CLIP. IN ADDITION, BLACK REMAINS INSIDE THE TIP OF THE PLUG AND THE STAFF HAVE TO TAKE A PAPER CLIP TO TRY TO REMOVE EVERYTHING, BUT DAMAGE IS STARTING TO OCCUR ON MANY OF THE WIRINGS. THIS HAS BEEN OCCURRING ON A DAILY BASIS FOR SEVERAL MONTHS. FURTHERMORE, ARTIFACTS HAVE BEEN MORE PRESENT FOR A FEW WEEKS ON THE HOLTERS AND EXAMINATIONS ARE 4X LONGER TO DECODE, AND SOME ARRHYTHMIA COULD NOT BE SPOTTED UNDER THE ARTIFACTS. ON 16SEP2025 CUSTOMER STATED THAT NO PATIENTS WERE INJURED. HOWEVER, THE ELECTRODE WIRES BECOME DAMAGED WHEN ATTEMPTING TO REMOVE THE BLACK TIP INSIDE THE ELECTRODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302883 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THEY HAD AN INCIDENT WITH ELECTRODE 22855 AND A PATIENT WAS HARMED IN THE MRI. ON 19AUG2025 ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT HAD AN MRCP ORDERED AND AFTER THE EXAM, WHICH LASTED ABOUT 15 MINUTES, THE PATIENT COMPLAINED OF WARMTH TO THE UPPER LEFT CHEST. IT WAS DETERMINED THAT ONE OF THE FOAM ELECTRODES ON THE UPPER LEFT CHEST HAD BEEN LEFT DURING THE EXAM. THE PATIENT HAD BEEN SCANNED FOR METAL, BUT THIS ELECTRODE DOES NOT SCAN. THE TECH LOOKED UNDER THE ELECTRODE IMMEDIATELY AFTER THE SCAN AND ONLY SAW SLIGHT REDNESS. THE PATIENT HAS BEEN SEEN AT THE WOUND CARE CENTER FOR TREATMENT OF THE BURN. THE WOUND HAS BEEN CLASSIFIED AS A 3RD DEGREE BURN. IT WAS STATED THAT THE INSTRUCTIONS FOR USE WERE FOLLOWED. ON 21AUG2025 ADDITIONAL INFORMATION WAS RECEIVED STATING THAT 8 DAYS AFTER THE EVENT THE PATIENT WAS SEEN AT THE WOUND CARE CENTER (B)(6) 2025). THE PHYSICIAN DOCUMENTED A L ANTERIOR CHEST WALL 3RD DEGREE, FULL THICKNESS THERMAL BURN. THE WOUND WAS DEBRIDED, SILVADENE WAS CONTINUED. THE PATIENT WAS SEEN AGAIN ON (B)(6) 2025, THE WOUND IS CLASSIFIED AS FULL THICKNESS AND MEASURES 3.9CM LENGTH, 2.6CM WIDTH, 0.3CM DEPTH, 7.964CM/2

  Patient problems: Fluid Discharge; Full thickness (Third Degree) Burn; Necrosis

  MAUDE report 22890258 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT DURING A WASH/BATH, WHEN CHANGING THE DEVICES, THE NURSE OBSERVED 2 BURNS UNDER TWO ELECTRODES OF 2 CM IN DIAMETER. THESE BURNS ARE ASSOCIATED WITH THE GEL PRESENT IN THE COMPOSITION OF THE ELECTRODE SINCE THE SURFACE BURNT SKIN IS IDENTICAL TO THE GEL CONTAINED IN THE ELECTRODES. ONE BLISTER HAS THE PRESENCE OF PURULENT FLUID AND THE OTHER BLISTER HAS RUPTURED. THE SKIN UNDERNEATH HAS AN ERYTHEMA. THERE WERE NO CREAMS OR ANY OTHER PRODUCT ON THE BABY'S SKIN. TREATMENT INVOLVED BURN CARE WITH PRESCRIPTION AND ADJUSTMENT OF ANALGESIC TREATMENT. THE CHILD HAD BEEN EXPERIENCING PAIN FOR SEVERAL HOURS, ASSESSED UNDER EVENDOL3 0 6/15 DESPITE CONTINUOUS ADMINISTRATION OF MORPHINE AND ADMINISTRATION OF LEVEL 1 ANALGESIC. FAILURE OF HEALING, RISK OF INFECTION.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 22865596 ↗
• MalfunctionAug 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE CLINICAL TEAMS ARE EXPERIENCING THE ADAPTERS/LEADS READING FALSE LOW HEART RATE AND SOME OF THE ADAPTERS HAVE CORRODED PINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22773431 ↗
• MalfunctionAug 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE CLINICAL TEAMS ARE EXPERIENCING THE ADAPTERS/LEADS READING FALSE LOW HEART RATE AND SOME OF THE ADAPTERS HAVE CORRODED PINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22773414 ↗

Other Cardinal Health 200, LLC products

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• 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
• Kangaroo35 models · 130 reports
• NOVAPLUS7 models · 75 reports · 1 recall