ArgyleRecalls & reported problems across all models
Cardinal Health 200, LLC · 33 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
7 open recalls name at least one Argyle model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 58
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 7
We found 33 models of Argyle by Cardinal Health 200, LLC in the FDA's device registry (GUDID). Together they are named in 58 adverse event reports in the FDA's MAUDE database, received between Sep 7, 2017 and Sep 11, 2026 — classified as 6 injuries, 52 malfunctions.
The most frequently reported specific device problem is “Break” (13 reports).
7 FDA recall records name at least one of these models by its device identifier, 7 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
Argyle 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.
- May 2, 2025Class IIOpen, Classified
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Z-1875-2025 · Root cause: Package design/selection · Recall details · FDA record ↗
- May 2, 2025Class IIOpen, Classified
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Z-1874-2025 · Root cause: Package design/selection · Recall details · FDA record ↗
- May 2, 2025Class IIOpen, Classified
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Z-1873-2025 · Root cause: Package design/selection · Recall details · FDA record ↗
- May 2, 2025Class IIOpen, Classified
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Z-1872-2025 · Root cause: Package design/selection · Recall details · FDA record ↗
- May 2, 2025Class IIOpen, Classified
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Z-1871-2025 · Root cause: Package design/selection · Recall details · FDA record ↗
- May 2, 2025Class IIOpen, Classified
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Z-1870-2025 · Root cause: Package design/selection · 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-1043-2024 · Root cause: Nonconforming Material/Component · names 7 of these models · Recall details · FDA record ↗
Most reported Argyle problems
Device problems
- Break13
- Crack12
- Connection Problem6
- Detachment of Device or Device Component6
- Fluid/Blood Leak6
- Kinked4
- Suction Problem4
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- Foreign Body In Patient5
- No Consequences Or Impact To Patient4
- No Information4
- No Known Impact Or Consequence To Patient3
- Insufficient Information1
- No Patient Involvement1
- Unspecified Heart Problem1
Argyle models
33 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Argyle 8888160333CATHETER, UMBILICAL ARTERY1 recall7 reports
- Argyle 8888160341CATHETER, UMBILICAL ARTERY1 recall1 report
- Argyle 8888160556CATHETER, UMBILICAL ARTERY1 recall1 report
- Argyle 8888160119CATHETER, UMBILICAL ARTERY1 recall0 reports
- Argyle 8888160325CATHETER, UMBILICAL ARTERY1 recall0 reports
- Argyle 8888160648CATHETER, UMBILICAL ARTERY1 recall0 reports
- Argyle 10102CATHETER AND TIP, SUCTION1 recall0 reports
- Argyle 10142CATHETER AND TIP, SUCTION1 recall0 reports
- Argyle 12082CATHETER AND TIP, SUCTION1 recall0 reports
- Argyle 12102CATHETER AND TIP, SUCTION1 recall0 reports
- Argyle 12142CATHETER AND TIP, SUCTION1 recall0 reports
- Argyle 12182CATHETER AND TIP, SUCTION1 recall0 reports
- Argyle 12191CATHETER AND TIP, SUCTION1 recall0 reports
- Argyle 8888505016APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED10 reports
- Argyle 8888505016APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED8 reports
- Argyle 461008TUBES, GASTROINTESTINAL (AND ACCESSORIES)5 reports
- Argyle 8888505115APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED3 reports
- Argyle 8888505172CATHETER AND TIP, SUCTION3 reports
- Argyle 8888505115APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED2 reports
- Argyle 31000CATHETER AND TIP, SUCTION2 reports
- Argyle 888570549KCATHETER AND TIP, SUCTION2 reports
- Argyle 460604TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 reports
- Argyle 8888160432CATHETER, UMBILICAL ARTERY2 reports
- Argyle 461008Tubes, gastrointestinal (and accessories)1 report
- Argyle 8888256545CATHETERS, SUCTION, TRACHEOBRONCHIAL1 report
- Argyle 43304Catheter, intravascular, therapeutic, short-term less than 30 days1 report
- Argyle 43311Catheter, intravascular, therapeutic, long-term greater than 30 days1 report
- Argyle 460711TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 report
- Argyle 461206TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 report
- Argyle 8888160119CATHETER, UMBILICAL ARTERY1 report
- Argyle 8888505024APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 report
- Argyle 8888505164CATHETER AND TIP, SUCTION1 report
- Argyle 5558505136CATHETER AND TIP, SUCTION1 report
Recent Argyle adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Connection Problem
The customer reported that the umbilical catheter end did not secure properly to the stopcock. One retained sample reportedly appeared to be missing part of the lip at the catheter end. The clinical staff reported difficulty achieving a secure connection with the stopcock. Additional information was received from the customer and stated that the issue seemed to occur while the line was on. It appeared the lip at the end of the catheter may have been stripped away. There was no harm reported. Unfortunately, the customer did not have any more additional information.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50731551 ↗MalfunctionMay 29, 2026Crack
THE CUSTOMER REPORTED THAT THE TIPS WERE CLEAR AND NORMAL WHEN THEY ARE IN THEIR PACKAGING BUT WHEN REMOVED AND CONNECTED TO THE MACHINE AFTER SOME TIME THE TIPS TURNS CLOUDY AND CRACKS. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25333999 ↗MalfunctionMay 26, 2026Crack
THE CUSTOMER REPORTED THAT THE TIPS WERE CLEAR AND NORMAL WHEN THEY ARE IN THEIR PACKAGING BUT WHEN REMOVED AND CONNECTED TO THE MACHINE AFTER SOME TIME THE TIPS TURNS CLOUDY AND CRACKS. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25289686 ↗MalfunctionMay 1, 2026Crack
THE CUSTOMER REPORTED THAT THE TIPS WERE CLEAR AND NORMAL WHEN THEY ARE IN THEIR PACKAGING BUT WHEN REMOVED AND CONNECTED TO THE MACHINE AFTER SOME TIME THE TIPS TURNS CLOUDY AND CRACKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25058807 ↗MalfunctionMar 23, 2026Break
THE CUSTOMER REPORTED THE SUCTION CATHETER TOP SNAPPED OFF WHEN PATIENT WAS HAVING DESATS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24662504 ↗MalfunctionMar 11, 2026Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE DOUBLE LUMEN PICC LEAKED AT SECOND LUMEN UNDER HUB CLOSEST TO PATIENT. NEONATAL NURSE PRACTITIONER (NNP) WAS NOTIFIED, THE PICC WAS DISCONTINUED, BLOOD CULTURE FOR PIV INSERTION WAS SENT, VANCOMYCIN X1 GIVEN. THE CUSTOMER FURTHER STATED THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THEY BELIEVE THAT THE VANCOMYCIN WAS GIVEN PROPHYLACTICALLY WHEN THE LINE WAS DISCOVERED TO BE LEAKING. THE CUSTOMER ALSO MENTIONED THEY DON'T HAVE ANY ADDITIONAL INFORMATION ON THE BLOOD CULTURE REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24571420 ↗MalfunctionFeb 10, 2026Connection Problem
THE CUSTOMER REPORTED THAT ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETERS ARE NOT STAYING CONNECTED TO THE STOPCOCKS. IT OCCURS WITH EVERY ONE OF THEM THAT THEY HAVE OPENED. THE CONNECTOR ENDS DO NOT LOCK, THE TABS SEEM TO BE SLIPPING IN THE LUERLOCK OF THE STOPCOCKS. THEY JUST KEEP SPINNING, AND IF THEY APPLY ANY PULLING PRESSURE, THEY CAN PULL THEM RIGHT OUT. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24310720 ↗InjuryFeb 5, 2026Material Puncture/Hole
THE CUSTOMER REPORTED THAT DURING RIGHT MINIMALLY INVASIVE THORACOSCOPIC OPERATION FOR A PNEUMOTHORAX, A 28FR STRAIGHT CHEST TUBE WAS PLACED THROUGH ONE OF THE INCISIONS AT THE CONCLUSION OF THE OPERATION. ON A POSTOPERATIVE FILM, THE CUSTOMER OBSERVED A RADIO-OPAQUE STRUCTURE ALONG THE CHEST TUBE IN THE SOFT TISSUE NEAR THE INCISION. THIS CORRESPONDS TO THE RADIO-OPAQUE SIDE HOLE OF THE TUBE THAT IS CUT BY THE MANUFACTURER OF THE TUBE PRIOR TO PACKAGING. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THERE WAS NO ADDITIONAL BREAKAGE TO CATHETER, IT WAS THE CUT OUT SIDE HOLE PIECE. ACCORDING TO THE CUSTOMER, THE PIECE WAS EVENTUALLY REMOVED FROM THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 24274853 ↗MalfunctionJan 12, 2026
DURING RIGHT MINIMALLY INVASIVE THORACOSCOPIC OPERATION FOR A PNEUMOTHORAX, AT THE CONCLUSION OF THE OPERATION A CHEST TUBE WAS PLACED THROUGH ONE OF THE INCISIONS - 28FR STRAIGHT CHEST TUBE. ON A POSTOPERATIVE FILM, I NOTICED A RADIO-OPAQUE STRUCTURE ALONG THE CHEST TUBE IN THE SOFT TISSUE NEAR THE INCISION. THIS CORRESPONDED TO THE RADIO-OPAQUE SIDE HOLE OF THE TUBE THAT IS CUT BY THE MANUFACTURER OF THE TUBE PRIOR TO PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24031483 ↗MalfunctionDec 10, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED AIR/OXYGEN IN THE LINE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THEY DID NOT OBSERVE ANY CRACKS, HOLES OR BREAKS IN THE LINE. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23771353 ↗MalfunctionDec 9, 2025Crack; Crack
PER CUSTOMER, THE HEALTH CARE PROFESSIONAL (HCP) REPORTED A LONG CRACK IN YANKUER SUCKER. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23761288 ↗MalfunctionDec 5, 2025Crack; Crack
THE CUSTOMER REPORTED THAT UPON OPENING A PACKAGE OF MATERIAL, THEY DISCOVERED TWO CANNULAS WITH FISSURES. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23732335 ↗MalfunctionOct 16, 2025Break; Break
CUSTOMER REPORTS: WHEN ATTEMPTING TO USE SUCTION DURING RESUSCITATION AFTER DELIVERY OF A BABY, THE SUCTION CATHETER WAS FOUND BROKEN WHERE THE CATHETER MEETS THE PLASTIC THUMB PORT PORTION. ACCORDING TO THE REPORT, THERE WAS NO SERIOUS HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23310103 ↗MalfunctionSep 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE DEVICE BROKE OFF WHILE BEING USED DURING A TKA (TOTAL KNEE ARTHROPLASTY). ADDITIONAL INFORMATION RECEIVED ON 22AUG2025 STATED THAT IT WAS THE TIP OF THE YANKAUER THAT BROKE OFF. IT WAS VISIBLE IN THE WOUND AND REMOVED WITHOUT COMPLICATION. NO INTERVENTION OR TREATMENT REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23025887 ↗MalfunctionSep 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE CATHETER NOTED TO BE LEAKING IV FLUIDS AT THE CONNECTION BETWEEN THE CATHETER AND THE BUTTERFLY PLASTIC CLIP PORTION. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23025884 ↗
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
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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