DoverRecalls & reported problems across all models
Cardinal Health, Inc. · 90 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
12 open recalls name at least one Dover model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 226
- Deaths reported
- 1
- Injuries reported
- 20
- Recalls
- 12
We found 90 models of Dover by Cardinal Health, Inc. in the FDA's device registry (GUDID). Together they are named in 226 adverse event reports in the FDA's MAUDE database, received between Oct 3, 2016 and Feb 16, 2026 — classified as 1 death, 20 injuries, 205 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (60 reports).
12 FDA recall records name at least one of these models by its device identifier, 12 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
Dover 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.
- Dec 4, 2023Class IOpen, Classified
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Z-1052-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Dec 4, 2023Class IOpen, Classified
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Z-1051-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Dec 4, 2023Class IOpen, Classified
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Z-1050-2024 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗
- Dec 4, 2023Class IOpen, Classified
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Z-1048-2024 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗
- Dec 4, 2023Class IOpen, Classified
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Z-1047-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Dec 4, 2023Class IOpen, Classified
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Z-1046-2024 · Root cause: Nonconforming Material/Component · names 3 of these models · Recall details · FDA record ↗
- Dec 4, 2023Class IOpen, Classified
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Z-1045-2024 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗
- Nov 1, 2022Class IIOpen, Classified
Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
Z-0361-2023 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- Nov 1, 2022Class IIOpen, Classified
Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
Z-0360-2023 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- Nov 1, 2022Class IIOpen, Classified
Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
Z-0359-2023 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- Nov 1, 2022Class IIOpen, Classified
Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
Z-0358-2023 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- Nov 1, 2022Class IIOpen, Classified
Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
Z-0356-2023 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported Dover problems
Device problems
- Detachment of Device or Device Component60
- Unintended Deflation38
- Deflation Problem30
- Obstruction of Flow26
- Failure to Deflate15
- Material Rupture15
- Difficult to Remove7
- Infusion or Flow Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions133
- No Consequences Or Impact To Patient35
- Pain12
- No Patient Involvement11
- Foreign Body In Patient7
- Urinary Retention6
- Insufficient Information5
- No Code Available5
Dover models
90 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Dover P4P14TSDUrinary Drainage Collection Kit1 recall12 reports
- Dover P4P16CSDKUrinary Drainage Collection Kit1 recall6 reports
- Dover 3450LFTray, catheterization, sterile urethral, with or without catheter (kit)1 recall3 reports
- Dover 6146LLCATHETER, RETENTION TYPE, BALLOON1 recall3 reports
- Dover 3450Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 recall1 report
- Dover 8887600776Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 recall0 reports
- Dover 8887600784Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 recall0 reports
- Dover 1814CATHETER, UROLOGICAL1 recall0 reports
- Dover 2480Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 recall0 reports
- Dover 3410Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 recall0 reports
- Dover 3420Tray, catheterization, sterile urethral, with or without catheter (kit)1 recall0 reports
- Dover 6140COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 recall0 reports
- Dover 8949Collector, Urine, (And Accessories) For Indwelling Catheter1 recall0 reports
- Dover 6148LLCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 recall0 reports
- Dover 7946Catheter, Urethral1 recall0 reports
- Dover P4P16CSDCatheter, Retention Type, Balloon1 recall0 reports
- Dover P4P18CSDKUrinary Drainage Collection Kit1 recall0 reports
- Dover 6162MFUrinary Drainage Collection Kit18 reports
- Dover 8887605148Tray, catheterization, sterile urethral, with or without catheter (kit)13 reports
- Dover 402716CATHETER, UROLOGICAL11 reports
- Dover 8887605163Tray, catheterization, sterile urethral, with or without catheter (kit)10 reports
- Dover P4P16XTSDEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE10 reports
- Dover P4P16TSDEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE10 reports
- Dover 7000COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER8 reports
- Dover 8887603085Tray, catheterization, sterile urethral, with or without catheter (kit)7 reports
- Dover 8944MFCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER7 reports
- Dover 1614CATHETER, UROLOGICAL6 reports
- Dover 8887605163Tray, catheterization, sterile urethral, with or without catheter (kit)5 reports
- Dover 3570CATHETER, UROLOGICAL5 reports
- Dover 8887605189Tray, catheterization, sterile urethral, with or without catheter (kit)4 reports
- Dover 605189ICCATHETER, RETENTION TYPE, BALLOON4 reports
- Dover 6155MFUrinary Drainage Collection Kit4 reports
- Dover 6156MFUrinary drainage collection kit3 reports
- Dover 7006LLCATHETER, RETENTION TYPE, BALLOON3 reports
- Dover 8887630203Tray, catheterization, sterile urethral, with or without catheter (kit)3 reports
- Dover 8887605189Catheter, Retention Type, Balloon3 reports
- Dover 8887688227CATHETER, UROLOGICAL3 reports
- Dover 8887605148Tray, catheterization, sterile urethral, with or without catheter (kit)2 reports
- Dover 400614CATHETER, UROLOGICAL2 reports
- Dover 20514CCATHETER, UROLOGICAL2 reports
- Dover 20516CCATHETER, UROLOGICAL2 reports
- Dover 1512CCATHETER, RETENTION TYPE, BALLOON2 reports
- Dover 8887603101Tray, catheterization, sterile urethral, with or without catheter (kit)2 reports
- Dover 40524LCATHETER, UROLOGICAL2 reports
- Dover 7016MFUrinary Drainage Collection Kit2 reports
- Dover 6950COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER2 reports
- Dover P4P18TSDEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE2 reports
- Dover 50516TCATHETER, UROLOGICAL2 reports
- Dover 7008LLCATHETER, RETENTION TYPE, BALLOON1 report
- Dover 6206COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 report
- Dover 6300COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 report
- Dover 6600URINOMETER, MECHANICAL1 report
- Dover 6308LLCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 report
- Dover 67000SYRINGE, IRRIGATING (NON DENTAL)1 report
- Dover 68800SYRINGE, IRRIGATING (NON DENTAL)1 report
- Dover 68820SYRINGE, IRRIGATING (NON DENTAL)1 report
- Dover 400610CATHETER, UROLOGICAL1 report
- Dover 400618CATHETER, UROLOGICAL1 report
- Dover 8888492041CATHETER, UROLOGICAL1 report
- Dover 8888492058CATHETER, UROLOGICAL1 report
- Dover 3141Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 report
- Dover 6165LLUrinary drainage collection kit, for indwelling catheter1 report
- Dover 1516CCatheter, Retention Type, Balloon1 report
- Dover 402720CATHETER, UROLOGICAL1 report
- Dover 1616CATHETER, UROLOGICAL1 report
- Dover 1619CATHETER, UROLOGICAL1 death1 report
- Dover 2822CATHETER, UROLOGICAL1 report
- Dover 8887605122Tray, catheterization, sterile urethral, with or without catheter (kit)1 report
- Dover 3558CATHETER, UROLOGICAL1 report
- Dover 3567CATHETER, UROLOGICAL1 report
- Dover 8887605205Catheter, Retention Type, Balloon1 report
- Dover 3623CATHETER, UROLOGICAL1 report
- Dover 2101Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 report
- Dover 605163ICCATHETER, RETENTION TYPE, BALLOON1 report
- Dover P4P16XSDUrinary Drainage Collection Kit1 report
- Dover FPP12ULUrinary drainage collection kit, for indwelling catheter1 report
- Dover FPP18ULUrinary drainage collection kit, for indwelling catheter1 report
- Dover 6158MFUrinary Drainage Collection Kit1 report
- Dover 7014MFUrinary Drainage Collection Kit1 report
- Dover 8946MFCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 report
- Dover 8948MFCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 report
- Dover 13716COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 report
- Dover 13718COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 report
- Dover 8887665161CATHETER, UROLOGICAL1 report
- Dover 20518ICCCATHETER, RETENTION TYPE, BALLOON1 report
- Dover 20520ICCCATHETER, RETENTION TYPE, BALLOON1 report
- Dover 145514BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE1 report
- Dover 145516BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE1 report
- Dover 8403CATHETER, URETHRAL1 report
- Dover 50514TCATHETER, UROLOGICAL1 report
Recent Dover adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2026Unintended Deflation
THE CUSTOMER REPORTED THAT WHEN CHANGING AN SV MORNING, THEY HAD A PROBLEM WITH THE BALLOON OF THE PROBE. BALLOON TESTED BEFOREHAND BUT "EXPLODED" FIVE MINUTES AFTER FITTING WHILE STILL IN PLACE. THE BALLOON WAS INFLATED TO 10CC. NOTE: SEVERAL ATTEMPTS TO GATHER INFORMATION FROM THE CUSTOMER WERE MADE. TO DATE, NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED.
Patient problems: Insufficient Information
MAUDE report 24346835 ↗MalfunctionJan 28, 2026Unintended Deflation
PER CUSTOMER, THE PATIENT REPORTED THE BALLOON ON THE FOLEY SEEMED TO HAVE A HOLE IN IT AND IT WOULD NOT STAY INFLATED. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24199349 ↗MalfunctionNov 3, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE PATIENT RECEIVED A FOLEY BALLOON TO HELP RIPEN HER CERVIX. IT WAS INFLATED TO THE STANDARD 60ML AND WHEN PLACED TO TENSION, THE BALLOON SLIPPED OUT OF THE PATIENT AND IT WAS DISCOVERED THAT THE FOLEY HAD POPPED INSIDE OF THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23456366 ↗MalfunctionMay 21, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE FOLEY CATHETER BALLOON HAS POPPED INSIDE THE PATIENT (WHILE FOLEY IN SITU) 3 TIMES IN A ROW. THE TWO OCCURRENCES HAPPENED WITHIN 36 HOURS. THE PATIENT COULD FEEL THE BALLOON POP AND THEN FOLEY FALLS OUT. PER CUSTOMER, ON THE PACKING FOR THIS PRODUCT IT STATES 5ML 2 WAY RETENTION; HOWEVER, ON THE FOLEY CATHETER ITSELF IT READS "INFLATE W/10MLS' ON THE BALLOON PORT. THE LAST 3 TIMES WHEN THE BALLOON POPPED, THE NURSES HAD INSTILLED 10 MLS INTO THE BALLOON AND THIS TIME AFTER REVIEWING THE PACKAGING FURTHER THEY INSTILLED 5 MLS INTO THE BALLOON. HOWEVER, THEY WERE UNABLE TO SEE IF THE LAST CATHETER BALLOON WOULD POP BECAUSE THE PHYSICIAN ORDERED THE FOLEY OUT. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22065049 ↗MalfunctionMay 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THERE WAS NO TIP TO THE CATHETER ON THE PATIENT¿S END AND IT WAS USED ON A PATIENT. THERE WAS NO HARM TO THE PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE NURSE COULD NOT 100% SAY IF IT WAS MISSING PRIOR TO PATIENT USE AS SHE NOTICED IT AFTER THE PRODUCT WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21980564 ↗MalfunctionMay 7, 2025Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT THEY OPENED A BOX AND A CATHETER IN THE BOX WAS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21980357 ↗MalfunctionMar 12, 2025Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT THE CATHETERS WERE COMING BENT AND NOT PACKED PROPERLY IN THE BOX. PER CUSTOMER, THE BOXES ARE IN PERFECT SHAPE, AND THE CATHETERS INSIDE ARE THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21585258 ↗MalfunctionFeb 20, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE BALLOON ON FOLEY BURST WITHIN THE FIRST DAY OF USE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21422222 ↗MalfunctionJan 29, 2025Material Twisted/Bent; Material Twisted/Bent
PER CUSTOMER, THE PATIENT STATED THAT THE CATHETERS WERE BENT. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21264228 ↗MalfunctionNov 6, 2024Material Rupture; Material Rupture
CUSTOMER REPORTS: THE BALLOON ON THE CATHETER SNAPPED (BURST). SOMETIMES IMMEDIATELY AFTER INSERTION, OTHER TIMES 2-3 DAYS AFTER INSERTION. THE END-USER'S URINE IS CLEAN AND HAS NO GRIT. THREE OCCURRENCES WERE REPORTED FOR LOT NUMBER 23B097FHX, THIS CASE REPRESENTS #3 OF THE 3 REPORTED CASES. THE BALLOON WAS REMOVED AS PER NORMAL PROCEDURE AND THE CATHETER HAS BEEN REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20620144 ↗MalfunctionNov 4, 2024Material Rupture; Material Rupture
CUSTOMER REPORTS: THE BALLOON ON THE CATHETER SNAPPED (BURST). SOMETIMES IMMEDIATELY AFTER INSERTION, OTHER TIMES 2-3 DAYS AFTER INSERTION. THE END-USER'S URINE IS CLEAN AND HAS NO GRIT. LOT NUMBER 23B097FHX. THE BALLOON WAS REMOVED AS PER NORMAL PROCEDURE AND THE CATHETER HAS BEEN REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20602270 ↗MalfunctionNov 4, 2024Material Rupture; Material Rupture
CUSTOMER REPORTS: THE BALLOON ON THE CATHETER SNAPPED (BURST). SOMETIMES IMMEDIATELY AFTER INSERTION, OTHER TIMES 2-3 DAYS AFTER INSERTION. THE END-USER'S URINE IS CLEAN AND HAS NO GRIT. LOT NUMBER 123K165FHX. THE BALLOON WAS REMOVED AS PER NORMAL PROCEDURE AND THE CATHETER HAS BEEN REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20601825 ↗MalfunctionNov 4, 2024Material Rupture; Material Rupture
CUSTOMER REPORTS: THE BALLOON ON THE CATHETER SNAPPED (BURST). SOMETIMES IMMEDIATELY AFTER INSERTION, OTHER TIMES 2-3 DAYS AFTER INSERTION. THE END-USER'S URINE IS CLEAN AND HAS NO GRIT. THREE OCCURRENCES WERE REPORTED FOR LOT NUMBER 23B097FHX, THIS CASE REPRESENTS # 2 OF THE 3 REPORTED CASES. THE BALLOON WAS REMOVED AS PER NORMAL PROCEDURE AND THE CATHETER HAS BEEN REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20601261 ↗MalfunctionOct 31, 2024Unintended Deflation; Unintended Deflation
PER CUSTOMER, THE HEAD OF THE UNIT HAVE DONE TEST WITH ONE CATHETER AND THE BALLOON LOST VOLUME OVER TIME. AFTER 1 WEEK, THE VOLUME WENT FROM 10 ML TO 3ML.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20579376 ↗InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER CUSTOMER, THE PATIENT (HIS WIFE) HAD CANCER, AND WAS USING A URINARY CATHETER, THAT REQUIRED THE USE OF STERILE SALINE, AND PRODUCTS ASSOCIATED WITH NURSE ASSIST TRAY. IN 2023, PATIENT¿S AT-HOME NURSE REPLACED HER CATHETER USING ONE OF THE NURSE ASSIST TRAYS THAT TURNED OUT TO BE THE PART OF A PRODUCT RECALL. THE NEXT DAY HIS WIFE HAD A FEVER, AND SHE HAD TO BE HOSPITALIZED. SHE WAS DIAGNOSED WITH AN INFECTION CAUSED BY CONTAMINATION FROM THE NURSE ASSIST KIT. PER CUSTOMER, HE DID NOT RECEIVE A LETTER ABOUT THE RECALL UNTIL 2024, AND HIS WIFE DIED IN 2024. AT THIS TIME THE CAUSE OF DEATH IS UNKNOWN, AND IT WAS UNKNOWN IF THERE WAS ANY CORRELATION BETWEEN THE REPORTED INCIDENT AND THE PATIENT¿S DEATH.
Patient problems: Fever; Unspecified Infection
MAUDE report 20567168 ↗
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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