Argyle 8888505115 (UDI 10192253038972)Recalls & reported problems
Cardinal Health 200, LLC · Yankauer Open Tip, No Vent · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10192253038972), received between Aug 20, 2025 and Sep 11, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionAug 20, 2025Break
BROKE OFF WHILE BEING USED DURING A TKA [TOTAL KNEE ARTHROPLASTY].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22850257 ↗
Other APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED devices
- StrykeFlow 0250070520Stryker Corporation · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED2 recalls250 reports
- StrykeFlow 0250070505Stryker Corporation · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall3 reports
- 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
- CRD 65651-510Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.