DoverRecalls & reported problems across all models
Cardinal Health 200, LLC · 45 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 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
- 241
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 2
We found 45 models of Dover by Cardinal Health 200, LLC in the FDA's device registry (GUDID). Together they are named in 241 adverse event reports in the FDA's MAUDE database, received between May 20, 2019 and Aug 28, 2026 — classified as 7 injuries, 234 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (136 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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-1046-2024 · Root cause: Nonconforming Material/Component · names 6 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-0357-2023 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported Dover problems
Device problems
- Detachment of Device or Device Component136
- Unintended Deflation38
- Material Twisted/Bent34
- Failure to Deflate6
- Obstruction of Flow5
- Deflation Problem4
- Break3
- Infusion or Flow Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions148
- No Consequences Or Impact To Patient57
- Insufficient Information15
- Foreign Body In Patient5
- No Known Impact Or Consequence To Patient5
- Discomfort4
- No Information4
- Urinary Retention3
Dover models
45 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Dover P4P16XTSDDEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE77 reports
- Dover P4P16TSDDEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE61 reports
- Dover 6144ICLLCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 recall2 reports
- Dover PP14SDCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 recall2 reports
- Dover PP16SDCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 recall1 report
- Dover 3408Tray, catheterization, sterile urethral, with or without catheter (kit)1 recall0 reports
- Dover 6153Urinary Drainage Collection Kit1 recall0 reports
- Dover 6154Urinary Drainage Collection Kit1 recall0 reports
- Dover PP18SDCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 recall0 reports
- Dover 8888492041CATHETER, UROLOGICAL13 reports
- Dover 400614CATHETER, UROLOGICAL9 reports
- Dover P4P16SDDEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE9 reports
- Dover 1614CATHETER, UROLOGICAL6 reports
- Dover 3560CATHETER, UROLOGICAL4 reports
- Dover 400612CATHETER, UROLOGICAL4 reports
- Dover 8888492025CATHETER, UROLOGICAL4 reports
- Dover 6208COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER4 reports
- Dover 1616CATHETER, UROLOGICAL3 reports
- Dover 1621CATHETER, UROLOGICAL3 reports
- Dover 1622CATHETER, UROLOGICAL3 reports
- Dover 402714CATHETER, UROLOGICAL3 reports
- Dover 8888492033CATHETER, UROLOGICAL3 reports
- Dover 20514CCatheter, urological2 reports
- Dover 1619CATHETER, UROLOGICAL2 reports
- Dover P4P16XSDUrinary drainage collection kit2 reports
- Dover 403722CATHETER, UROLOGICAL2 reports
- Dover 6308COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER2 reports
- Dover 7000LLCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER2 reports
- Dover 6148ICLLCATHETER, RETENTION TYPE, BALLOON2 reports
- Dover 20516CCatheter, urological1 report
- Dover 20518CCatheter, urological1 report
- Dover 2822CATHETER, UROLOGICAL1 report
- Dover 3607CATHETER, UROLOGICAL1 report
- Dover 402716CATHETER, UROLOGICAL1 report
- Dover 1518CCATHETER, RETENTION TYPE, BALLOON1 report
- Dover 1612CCATHETER, RETENTION TYPE, BALLOON1 report
- Dover 8888492017CATHETER, UROLOGICAL1 report
- Dover 8888492058CATHETER, UROLOGICAL1 report
- Dover 605148ICCATHETER, RETENTION TYPE, BALLOON1 report
- Dover 6261COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 report
- Dover 8887660903CATHETER, UROLOGICAL1 report
- Dover PP16XSDCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 report
- Dover PP16CSDCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 report
- Dover 6070Urinary Drainage Collection Kit1 report
- Dover P4P16CSDK2Urinary drainage collection kit, for indwelling catheter1 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.
MalfunctionAug 28, 2026Unintended Deflation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50503253 ↗MalfunctionApr 7, 2026Material Twisted/Bent
ACCORDING TO THE CUSTOMER, THE PATIENT STATED THAT DUE TO ALL SUPPLIES STUFFED IN 1 BOX, THEY WERE BENT AND SHE COULD NOT STRAIGHTEN THEM OUT. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24809296 ↗MalfunctionApr 7, 2026Nonstandard Device
THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO PERFORM A STRAIGHT CATHETER ON A PATIENT DUE TO NO HOLE IN THE TIP OF THE CATHETER. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24802509 ↗MalfunctionFeb 3, 2026Unintended Deflation
THE CUSTOMER REPORTED THAT THE CATHETERS SEEMED LIKE THERE WERE HOLES IN THE BALLOONS AND WOULD NOT STAY INFLATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT IT WAS ONLY ONE PATIENT WHO RECEIVED 3 INDIVIDUAL CATHETERS. THE ISSUE WAS NOTICED DURING CATHETER USE BY THE PATIENT. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24245827 ↗MalfunctionJan 22, 2026Material Twisted/Bent
THE CUSTOMER REPORTED THAT THE CATHETERS WERE BENT IN THE BOX THAT ARE CURVED AND REMAIN CURVED WHEN HE TAKES THEM OUT OF THE BOX, AND THEY DID NOT HAVE THE ORIGINAL STRAIGHT SHAPE. THE CLIENT MENTIONED THAT CAUSES PROBLEMS WITH INSERTION (DIFFICULT) BECAUSE THE CATHETER MUST BE STRAIGHT AS ORIGINALLY, BUT IT REMAINS CURVED BY A BAD FOLD IN THE BOX. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24157500 ↗MalfunctionDec 23, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE BALLOON DEFLATES ON ITS OWN. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THERE WAS NO PATIENT INVOLVED. THE CUSTOMER TESTED A 14 FR CATHETER USING STERILE WATER, AND THE BALLOON DEFLATED DURING TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23882370 ↗MalfunctionDec 22, 2025Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT THE CATHETERS WERE BENT AND TWISTED, AND SHE COULD NOT USE THEM. THERE WAS NO REPORTED HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23863244 ↗MalfunctionDec 18, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE BALLOON DEFLATES ON ITS OWN. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE PATIENT HAD TO RETURN TO THE CLSC FOR CATHETER REPLACEMENT. THE PATIENT HAD NO MEDICAL INTERVENTION OR TREATMENT, BUT THE PATIENT EXPERIENCED INCREASED INFECTION RISK AND SIGNIFICANT DISCOMFORT.
Patient problems: Discomfort
MAUDE report 23843541 ↗MalfunctionDec 18, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE BALLOON DEFLATES ON ITS OWN AND THE DEVICE HAS BEEN REPLACED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE CATHETER WAS INSTALLED ON (B)(6) 2025, AND IN THE AFTERNOON THE PATIENT HAD TO RETURN TO THE CLSC BECAUSE THE BALLOON DEFLATED, AND THE CATHETER FELL OFF. A NEW 18 FR CATHETER WAS RE-INSTALLED. ON (B)(6) 2025, RE-INSTALLED 18FR CATHETER ALSO HAD A BALLOON DEFLATION ISSUE AND IT WAS REPLACED BY ANOTHER 18 FR CATHETER AND THE ISSUE HAPPENED AGAIN WITH THE THIRD 18 FR CATHETER AS WELL. THE PATIENT HAD NO MEDICAL INTERVENTION OR TREATMENT, BUT THE PATIENT EXPERIENCED INCREASED INFECTION RISK AND SIGNIFICANT DISCOMFORT.
Patient problems: Discomfort
MAUDE report 23843093 ↗MalfunctionNov 20, 2025Material Twisted/Bent; Material Twisted/Bent
PER CUSTOMER, PATIENT STATED THAT CATHETERS WERE BENT AND UNUSABLE. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23610040 ↗MalfunctionNov 17, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE ITEM INSIDE THE KIT WAS FAULTY. ACCORDING TO THE CUSTOMER, WHEN THEY INSERTED LIQUID INTO THE BALLOON, IT LEAKED. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23573762 ↗MalfunctionNov 3, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE CERVICAL FOLEY BURST WHEN INFLATING INSIDE THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT IT WAS UNSURE IF THE BALLOON WAS RUPTURED WITH A PINHOLE OR LEAK. THE PATIENT DESCRIBED THE FEELING AS THE BALLOON HAVING¿ ¿BURST¿. ACCORDING TO THE CUSTOMER, THE BALLOON HAD A CLEAN TEAR AND IN ONE PIECE, THOUGH IT WAS FULLY DEFLATED. THERE WAS NO TREATMENT NEEDED AND THERE WAS NO PATIENT INJURY. THEY HAD TO RE-INSERT THE CATHETER WHICH CAUSED UNNECESSARY DISCOMFORT TO THE PATIENT INVOLVED.
Patient problems: Discomfort
MAUDE report 23453712 ↗MalfunctionNov 3, 2025Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT THE CATHETER TIPS WERE CRACKED AND BENT UP ON THE ENDS. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23453123 ↗MalfunctionNov 3, 2025Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED BENT CATHETERS. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23452714 ↗MalfunctionOct 24, 2025Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT THEY HAVE A CURVE AND DAMAGE IN THE UPPER PART, PREVENTING THEM FROM FUNCTIONING CORRECTLY. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23383273 ↗
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
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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