Argyle 8888505016 (UDI 10884527019946)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884527019946), received between Jun 18, 2019 and May 29, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Crack” (4 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJun 24, 2025Crack; Crack

  THE CUSTOMER REPORTED THAT CRACK IN THE YANKAUER WAS OBSERVED WHEN REMOVED FROM PACKAGING. AS A RESULT, THE DEVICE COULD NOT BE USED FOR PATIENT SUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323785 ↗
• MalfunctionApr 18, 2025Crack; Crack

  THE CUSTOMER REPORTED THAT THERE WAS A SLICE ALONG PART OF THE SEAM OF THE ITEM. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21867417 ↗
• MalfunctionMar 30, 2023Contamination; Device Contaminated During Manufacture or Shipping

  WE FOUND AN ARGYLE YANKAUER TIP THAT HAD A HAIR IN THE PACK. THE PACK WAS NOT OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16643679 ↗
• MalfunctionFeb 3, 2022Suction Problem; Suction Problem

  THE CUSTOMER REPORTED THAT THEY HAVE DISCOVERED THAT THE YANKAUERS BEING STOCKED ALL HAVE THE SAME REFERENCE NUMBER, BUT SOME HAVE HOLES IN THEM AND SOME DO NOT. THE BLUE ONES THEY USED TO STOCK NEVER HAD HOLES, YOU SIMPLY PLUG IT INTO THE SUCTION TUBING AND IT WORKS. THE ONE WITH THE HOLE, HOWEVER, DOES NOT SUCTION ADEQUATELY UNLESS YOU PUT YOUR FINGER OVER THE HOLE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 STATED THAT THE ISSUE WAS FOUND DURING PATIENT USE HOWEVER THE QUANTITY OF INVOLVED PATIENTS IS UNKNOWN AND NO INDIVIDUAL INCIDENT INFORMATION IS AVAILABLE. THERE WERE NO KNOWN INJURIES OR HARM. THE CUSTOMER FURTHER STATED THAT THIS IS THE MODEL OF YANKAUERS THEY HAVE ALWAYS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13444129 ↗
• InjuryApr 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTS: THE DISTAL PORTION ( APPROX. 3 ½ INCHES) OF THE YANKAUER SUCTION TIP BROKE OFF IN THE PATIENTS FEMORAL CANAL AND WAS UNABLE TO BE RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11723758 ↗
• MalfunctionApr 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THEY YANKAUER SUCTION DEVICE WAS FOUND TO BE MISSING THE DISTAL ROUNDED END OF THE TIP AFTER USING IT THE SECOND TIME. THE YANKAUER WAS USED IMMEDIATELY AFTER INTUBATION BY DOCTOR. IT WAS NOT NOTICED AT THE TIME THAT THE YANKAUER WAS FLAWED. THE FLAW WAS DISCOVERED DURING THE EMERGENCE PHASE. A NEW YANKAUER WAS USED. THE DOCTOR VISUALIZED THE AIRWAY POST PROCEDURE WITH GLIDESCOPE AND NO YANKAUER TIP WAS FOUND. ADDITIONAL INFORMATION PROVIDED ON APRIL 01, 2021 STATED THAT THERE WAS NO DIFFICULTY DURING SUCTIONING. THERE WAS NO INJURY TO THE PATIENT AND THERE WERE NO SIGNS OF AIRWAY OBSTRUCTION OR RESPIRATORY DISTRESS. THE GLIDESCOPE WAS USED TO VISUALIZE THE HYPOPHARYNX FOLLOWING THE PROCEDURE BUT NO TIP WAS OBSERVED AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648888 ↗
• MalfunctionJun 18, 2019Material Deformation; Material Deformation

  THE CUSTOMER REPORTS THE PLASTIC CONNECTION APPEARS TO HAVE MELTED AND DIMINISHED SUCTION. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8708545 ↗
• MalfunctionJun 18, 2019Material Deformation; Material Deformation

  THE CUSTOMER REPORTS THE PLASTIC CONNECTION APPEARS TO HAVE MELTED CAUSING DIMINISHED SUCTION. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8708458 ↗