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YANKAUER 0034880Recalls & reported problems

Conmed Corporation · YANKAUER Suction Instrument with Control Vent, Bulb Tip, Clear · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10653405000266), received between Jan 11, 2022 and Jul 31, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (3 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

Device problems

  • Delivered as Unsterile Product3

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 31, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

    DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0034880, FOR AN INSUFFICIENT HEATSEAL. THE DEVICE WAS ENCROACHING THE SEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17424779 ↗
  • MalfunctionOct 18, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

    DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0034880, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15623772 ↗
  • MalfunctionJan 11, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

    DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, (B)(4), FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13223841 ↗

Other APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.