Halyard 92794Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10680651927948), received between May 3, 2018 and Nov 22, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryNov 22, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3006646024-2019-00028 FOR THE SECOND EVENT. IT WAS REPORTED PHYSICIAN HAD "SEVERELY" CUT HERSELF ON THE SCALPEL IN THE PRODUCT KIT. THE INCIDENT HAPPENED WHEN TRYING TO REMOVE THE COVER OFF OF THE SCALPEL, THE SCALPEL HAD NOT BEEN USED ON A PATIENT AND WAS CLEAN. THE PHYSICIAN WENT TO THE EMERGENCY ROOM (ER) FOR TREATMENT AND WAS "OKAY" AT THAT TIME. THE NURSE WHO REPORTED THE INCIDENT NOTED THAT THE COVER SEEMED DIFFICULT TO REMOVE, AND WHEN THE PHYSICIAN APPLIED FORCE TO REMOVE THE COVER, THAT IS WHEN THE INCIDENT OCCURRED. THE PHYSICIAN CUT HERSELF ON HER RIGHT FOREARM.

  Patient problems: Laceration(s)

  MAUDE report 9363153 ↗
• InjuryNov 22, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3006646024-2019-00027 FOR THE FIRST EVENT. IT WAS REPORTED PHYSICIAN HAD "SEVERELY" CUT HERSELF ON THE SCALPEL IN THE PRODUCT KIT. THE INCIDENT HAPPENED WHEN TRYING TO REMOVE THE COVER OFF OF THE SCALPEL, THE SCALPEL HAD NOT BEEN USED ON A PATIENT AND WAS CLEAN. THE PHYSICIAN WENT TO THE EMERGENCY ROOM (ER) FOR TREATMENT AND WAS "OKAY" AT THAT TIME. THE NURSE WHO REPORTED THE INCIDENT NOTED THAT THE COVER SEEMED DIFFICULT TO REMOVE, AND WHEN THE PHYSICIAN APPLIED FORCE TO REMOVE THE COVER, THAT IS WHEN THE INCIDENT OCCURRED. THE PHYSICIAN CUT HER WRIST, INFORMATION WAS NOT PROVIDED IF IT WAS THE LEFT WRIST OR RIGHT WRIST.

  Patient problems: Laceration(s)

  MAUDE report 9363125 ↗
• MalfunctionMay 3, 2018Hole In Material

  THERE WAS A HOLE IN THE WALL SUCTION SET THAT PREVENTED THE FLUID FROM BEING SUCTIONED. DUE TO THIS, ANOTHER KIT HAD TO BE OPENED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7482673 ↗