KendallRecalls & reported problems across all models
Cardinal Health, Inc. · 35 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Kendall model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 58
- Deaths reported
- 1
- Injuries reported
- 18
- Recalls
- 1
We found 35 models of Kendall by Cardinal Health, Inc. in the FDA's device registry (GUDID). Together they are named in 58 adverse event reports in the FDA's MAUDE database, received between Jun 14, 2017 and Jan 8, 2026 — classified as 1 death, 18 injuries, 39 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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
Reports received per month, all models
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.
- Nov 6, 2023Class IOpen, Classified
Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.
Z-0513-2024 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
Most reported Kendall problems
Device problems
- Adverse Event Without Identified Device or Use Problem13
- Incorrect, Inadequate or Imprecise Result or Readings4
- Separation Problem4
- Break3
- Material Separation3
- Appropriate Device Problem Term/Code Not Available2
- Detachment of Device or Device Component2
- Difficult or Delayed Separation2
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Consequences Or Impact To Patient7
- No Known Impact Or Consequence To Patient4
- Rash3
- Skin Inflammation/ Irritation3
- Skin Irritation3
- Skin Tears3
- Burn(s)2
Kendall models
35 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Kendall 90SALDressing, wound, drug1 recall0 reports
- Kendall 210SALDressing, wound, drug1 recall0 reports
- Kendall ES40030Electrode, electrocardiograph9 reports
- Kendall 20770Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)5 reports
- Kendall 31469219Automated External Defibrillators (Non-Wearable)4 reports
- Kendall 40000006Automated External Defibrillators (Non-Wearable)1 death3 reports
- Kendall 2531CTape And Bandage, Adhesive2 reports
- Kendall 33527TCABLE, ELECTRODE2 reports
- Kendall 33135TCABLE, ELECTRODE2 reports
- Kendall 139093SCALPEL, ONE-PIECE2 reports
- Kendall 31424768Electrode, electrocardiograph2 reports
- Kendall 31424785Electrode, electrocardiograph2 reports
- Kendall 31078135Electrode, electrocardiograph2 reports
- Kendall 31319281Automated External Defibrillators (Non-Wearable)2 reports
- Kendall 6641Dressing, wound, occlusive1 report
- Kendall 55535Dressing, wound, occlusive1 report
- Kendall 9416CTape and bandage, adhesive1 report
- Kendall 3142CTape and bandage, adhesive1 report
- Kendall 3615CTape and bandage, adhesive1 report
- Kendall 5806CTape and bandage, adhesive1 report
- Kendall 33136TCABLE, ELECTRODE1 report
- Kendall 33110RCABLE, ELECTRODE1 report
- Kendall 1181200777KSyringe, piston1 report
- Kendall 131615SCALPEL, ONE-PIECE1 report
- Kendall 139090SCALPEL, ONE-PIECE1 report
- Kendall 9414CTape and bandage, adhesive1 report
- Kendall 30807732Electrode, electrocardiograph1 report
- Kendall EP30016Electrode, electrocardiograph1 report
- Kendall 31050522Electrode, electrocardiograph1 report
- Kendall 31115788Electrode, electrocardiograph1 report
- Kendall 22855Electrode, electrocardiograph1 report
- Kendall 40000013Electrode, electrocardiograph1 report
- Kendall 31013926Electrode, electrocardiograph1 report
- Kendall 33114CABLE, ELECTRODE1 report
- Kendall 6640Dressing, wound, occlusive1 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.
MalfunctionJan 8, 2026
PACKAGE FOUND INTACT WITH A BLACK SUBSTANCE ON THE INSIDE AND ON THE FOAM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24003282 ↗MalfunctionOct 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE BLADE BREAKS FROM THE HANDLE OF THE SCALPEL EASILY. THE ENTIRE BLADE IS DETACHING FROM THE HANDLE. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15678757 ↗MalfunctionOct 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE SCALPEL BREAKS EASILY. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT. PER ADDITIONAL INFORMATION PROVIDED ON OCTOBER 24, 2022, THE ENTIRE BLADE IS DETACHING FROM THE HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15673596 ↗MalfunctionJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT THEY HAVE HAD A STAFF MEMBER EXPERIENCE ANAPHYLAXIS REACTION. THE CUSTOMER WANTED TO INQUIRE IF THE ITEM CONTAINED LATEX BECAUSE THE BROCHURE SHOWS IT IN FACT CONTAINS LATEX YET THE PICTURE ON THE SITE SAYS HYPOALLERGENIC.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 15121245 ↗MalfunctionJul 8, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CVICU NURSE STATED THAT THEY ARE HAVING ISSUES WITH TRACINGS (ARTIFACT AND ASYSTOLE) WHEN THE LEAD SET IS USED WITH THEIR EXTERNAL PACING WIRES ON PATIENTS POST CABG. THEY ARE REMOVING KDL FROM THE OPERATING ROOM AND PLACING THEIR REUSABLES FROM PHILLIPS WITHOUT TRACING ISSUES. NO INJURIES HAVE OCCURRED. PER ADDITIONAL INFORMATION PROVIDED, THIS ISSUE HAPPENED WITH ALL OF THE NURSE'S PATIENTS WITH EXTERNAL PACER WIRES THAT CAME FROM THE OR WITH KDL. THEY ALWAYS SWITCHED BACK TO REUSABLE CABLE/LEADSETS WITH EXTERNAL PACER WIRES AND THE ISSUE WAS RESOLVED. NO FURTHER INFORMATION IS AVAILABLE ABOUT EACH SPECIFIC INCIDENT OR THE EXACT NUMBER OF PATIENTS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14957232 ↗MalfunctionApr 13, 2022Break; Break
THE CUSTOMER REPORTED THAT THE BLADE WAS DETACHED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE BROKEN BLADE WAS DISCOVERED WHEN OPENED ON THE TRAY. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14105123 ↗MalfunctionMar 24, 2022Fire; Fire
THE CUSTOMER REPORTED THAT THE DEFIBRILLATOR PADS FOR ZOLL (KENDALL 20770 ADULT MULTI-FUNCTION DEFIBRILLATION ELECTRODES) SPARKED A SMALL FLAME WHEN DEFIBRILLATING A PATIENT IN V-FIB IN THE EMERGENCY ROOM. THE PATIENT WAS CONNECTED TO A LUCAS MACHINE WHEN THE EVENT HAPPENED. DEFIBRILLATION APPEARED TO PROPERLY CONDUCT THROUGH PADS BUT ONE OF THE PADS WAS SHORT CIRCUITED AFTER THE EVENT WITH APPARENT BURN MARKS ON SAID PAD. PADS WERE REPLACED ON PATIENT AND NO APPARENT INJURY TO PATIENT WAS NOTED, HOWEVER THE CODE WAS CALLED SHORTLY AFTER EVENT SO IT WAS UNABLE TO BE DETERMINED IF THE PADS CAUSED ANY CHANGE TO PATIENT STATUS. PADS WERE NOTED TO BE PROPERLY SECURED TO THE PATIENT PRIOR TO EVENT AND PLUGGED IN PROPERLY. ZOLL WAS FUNCTIONING PROPERLY AS WELL AND HAD PASSED THE SAFETY CHECKS FOR THE DAY. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON (B)(6) 2022 CONFIRMED THAT THE PATIENT'S DEATH WAS NOT RELATED TO THE REPORTED PRODUCT PROBLEM. THE INSTRUCTIONS FOR USE WERE FOLLOWED FOR SKIN PREP. THERE WAS MINIMAL HAIR PER THE STAFF. THE PATIENT WAS DIAPHORETIC BUT STAFF STATED THEY DRIED THE PATIENT OFF. ALONG WITH THE DEFIB, THE PATIENT HAD EKG WIRES, OXYGEN, AND AN ET TUBE. IT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13875707 ↗MalfunctionMar 24, 2022Fire; Fire
THE CUSTOMER REPORTED THAT THE DEFIBRILLATOR PADS FOR ZOLL (KENDALL 20770 ADULT MULTI-FUNCTION DEFIBRILLATION ELECTRODES) SPARKED A SMALL FLAME WHEN DEFIBRILLATING A PATIENT IN V-FIB IN THE EMERGENCY ROOM CAUSING A LUCAS MACHINE OWNED BY AMR TO SHORT CIRCUIT. PADS WERE NOTED TO BE PROPERLY SECURED TO THE PATIENT PRIOR TO EVENT AND PLUGGED IN PROPERLY. ZOLL WAS FUNCTIONING PROPERLY AS WELL AND HAD PASSED THE SAFETY CHECKS FOR THE DAY. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON 21-MAR-2022 STATED THAT THERE WAS NO PATIENT INJURY OR DEATH. THE INSTRUCTIONS FOR USE WERE FOLLOWED FOR SKIN PREP. IT IS UNKNOWN IF THE ELECTRODE AREA WAS FREE OF HAIR OR DRY. ALONG WITH THE DEFIB, THE PATIENT HAD EKG WIRES, OXYGEN, AND AN ET TUBE. IT IS UNKNOWN HOW MANY SHOCKS THE PATIENT RECEIVED AND UNKNOWN HOW MANY JOULES. IT IS NOT KNOWN WHEN OR WHERE ON THE DEVICE THE SPARK/FLAME OCCURRED. THE FLAME WENT OUT ON IT'S OWN. PATIENT INFORMATION IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13875593 ↗MalfunctionMar 8, 2022Failure to Analyze Signal; Failure to Analyze Signal
THE CUSTOMER REPORTED THAT DURING USE, AN ECG WAS REQUESTED. THE ELECTRODES WERE PLACED ON THE PATIENT IN THE CORRECT PLACES AND DOUBLE CHECKED USING VERY CAREFUL ANATOMICAL LANDMARKS. DUE TO THE MALFUNCTION OF THE ELECTRODES, IT WAS POSSIBLE TO OBSERVE SEVERAL ARTIFACTS DURING THE READING OF THE ECG WHICH MADE THE READING INCOMPREHENSIBLE. SOMETIMES, THERE WAS ALSO AN ABSENCE OF CURRENT FLOW IN THE ELECTRODES WHICH CREATED AN ASYSTOLE, EVEN IF THE PATIENT WAS IN PERFECT HEALTH. A SECOND ECG MACHINE WAS TRIED, AND THE SAME MALFUNCTION WAS OBSERVED. THESE 2 ECGS HAVE BEEN VERIFIED BY A BIOMED TECH IN THE LAST FEW MONTHS. THE SAME TEST WITH A DIFFERENT LOT WAS DONE AND NO PROBLEMS WERE DETECTED WITH THE NEW LOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13685825 ↗InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THE PATIENT WAS RED WITH A RASH AND WAS ITCHY BEYOND THE ELECTRODE AREA. DIRECTIONS FOR ELECTRODE PREP WERE FOLLOWED. THE PATIENT CONSULTED A CLINICIAN AND WAS PRESCRIBED (B)(6).
Patient problems: Rash
MAUDE report 12989057 ↗InjuryNov 16, 2021Break; Break
THE CUSTOMER REPORTED THAT DURING THE SURGICAL PROCEDURE, THE BLADE FROM THE SCALPEL BROKE IN HALF INSIDE THE PATIENT'S KNEE. A LARGER INCISION NEEDED TO BE MADE TO REMOVE THE BROKEN PIECE. THE BROKEN BLADE WAS REMOVED IN ONE PIECE AND PER PROTOCOL, AN XRAY WAS TAKEN TO VERIFY THERE WAS NO PRODUCT LEFT BEHIND. THERE WAS NO HARM TO THE PATIENT OR STAFF DUE TO THIS BROKEN SCALPEL BLADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12824820 ↗InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORT AN ALLERGIC REACTION TO ECG ELECTRODES THAT CAUSED AN ANAPHYLACTIC REACTION, ASTHMA ATTACK AND HIVES AFTER A SLEEP STUDY.
Patient problems: Anaphylactic Shock; Asthma
MAUDE report 12741189 ↗InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT THE ELECTRODE WAS REMOVED FROM THE SKIN LEAVING BEHIND A SMALL 2X2CM SKIN ABRASION WHICH WAS OOZING. PER ADDITIONAL INFORMATION RECEIVED, THE BABY HAD PUS LIKE FLUID DRAINING FROM THE AFFECTED SITE. INITIAL CARE OF A SALINE CLEAN AND A COMFEEL COVERING WAS GIVEN. THE PEDIATRICIAN PRESCRIBED BACTROBAN OINTMENT IN THE HOSPITAL AND THE BABY WENT HOME FULLY HEALED. THERE WAS NO MEDICAL PROCEDURE FOR THE SKIN LESION. THE DURATION OF USE OF THE ELECTRODE WAS FOR ABOUT 2 DAYS.
Patient problems: Abrasion
MAUDE report 12668704 ↗InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT THE ELECTRODE TOOK OFF TOP LAYER OF THE SKIN LEAVING BEHIND A 2.5X2.5 CM LESION OOZING GREEN FLUID. PER ADDITIONAL INFORMATION RECEIVED, INITIAL CARE OF A SALINE CLEAN AND A COMFEEL COVERING WAS GIVEN. THE PEDIATRICIAN PRESCRIBED BACTROBAN OINTMENT IN THE HOSPITAL AND THE BABY WENT HOMED FULLY HEALED. THERE WAS NO MEDICAL PROCEDURE FOR THE SKIN LESION. THE DURATION OF USE OF THE ELECTRODE WAS FOR ABOUT 2 DAYS.
Patient problems: Localized Skin Lesion
MAUDE report 12665626 ↗MalfunctionOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTER STATED THAT SHE HAD AN ALLERGIC REACTION TO THE ELECTRODE PATCHES AND HAS BURN LIKE INJURIES ON HER BODY. ADDITIONAL INFORMATION PROVIDED STATED THAT HER THROAT STARTED TO CLOSE MAKING THIS A LIFE THREATENING SITUATION. THE REACTION WAS LOCATED ON HER CHEST AND UNDER HER LEFT BREAST. SHE REACTED TO ALL FIVE ELECTRODES USED. SHE CONSULTED HER ALLERGIST BECAUSE SHE FELT SHORT OF BREATH. SHE WAS PRESCRIBED 50MG OF BENADRYL WHICH SHE TOOK EVERY EIGHT HOURS FOR TWO DAYS AND ONE DOSE OF 20MG OF PREDNISONE. SHE ALSO SELF-TREATED BY WASHING THE AREAS WITH SOAP AND WATER TO REMOVE THE GEL AND PATTED THE AREAS DRY. THE AREAS WERE BLISTERING SO SHE LEFT THEM OPEN IN THE AIR UNTIL SCABS FORMED. SHE NOW HAS SCARS IN THE AFFECTED AREAS.
Patient problems: Blister; Dyspnea; Hypersensitivity/Allergic reaction; Scar Tissue
MAUDE report 12594397 ↗
Other Cardinal Health, Inc. products
All Cardinal Health, Inc. devices →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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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