Argyle 8888505016 (UDI 10192253038996)Recalls & reported problems
Cardinal Health 200, LLC · Yankauer Bulb Tip, No Vent · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10192253038996), received between Jun 24, 2025 and May 1, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Crack” (7 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Crack7
- Suction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗MalfunctionAug 14, 2025Crack; Crack
THE CUSTOMER REPORTED DEVICE ARRIVED ALREADY CRACKED ABOVE THE BULB WHICH MEANS THAT THE SUCTION IS NOT OPTIMAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22812467 ↗MalfunctionAug 7, 2025Crack; Crack
THE CUSTOMER REPORTED THAT THE SUCTION YANKAUER NEW IN PACKAGE HAS CRACK ON MULTIPLE SUPPLIES IN SAME PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22745526 ↗MalfunctionJun 26, 2025Crack; Crack
THE CUSTOMER REPORTED THAT THE PHYSICIAN FOUND SUCTION DEVICE WITH CRACKS WHICH CAUSED LACK OF SUCTION. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22340775 ↗MalfunctionJun 24, 2025Crack; Crack
THE CUSTOMER REPORTED THAT SUCTION MALFUNCTION OCCURRED DUE TO LARGE CRACK ON SUCTION YANKAUER WHEN SUCTIONING WAS NEEDED FOR PATIENT. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22323638 ↗MalfunctionJun 24, 2025Suction Problem; Suction Problem
THE CUSTOMER REPORTED THAT THE PROBLEM WAS THAT THE TUBE DOESN'T SUCK; IT'S AS IF THE SUCTION PORT WAS BLOCKED BY PLASTIC. PER THE CUSTOMER, THEY USED THREE TUBES, AND ONLY ONE WORKED. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22322971 ↗
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- Altitude 8888571370Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Aqua-Seal 8888571315Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Sentinel Seal 8888571513Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Sentinel Seal 8888571562Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- spineX BONE DUST COLLECTOR S-4500Oto-Med, Inc. · Apparatus, Suction, Operating-Room, Wall Vacuum Powered1 recall0 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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