Halyard 46767Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20680651467670), received between Aug 28, 2018 and Jun 19, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2023Break; Break

  THE N95 MASK SHOWED DAMAGE DURING HANDLING. THE ELASTIC STRIPS ARE BURSTING. ONE OF THE SPRINGS CAME OFF. PUTTING ON THE MASK CAUSES THE SPRING TO BURST. INCIDENT WAS REPORTED TO HAVE OCCURRED DURING PRODUCT USE. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17152129 ↗
• MalfunctionJun 15, 2023Break; Break

  THE STRAPS ARE BREAKING ON MULTIPLE LOTS DURING USE. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17140827 ↗
• MalfunctionJun 15, 2023Break; Break

  WE RECEIVED COMPLAINTS ABOUT THE QUALITY OF THE MASK. WHEN HANDLING THE MASK THE ELASTIC BREAKS. THIS INCIDENT OCCURRED IN THE INTENSIVE CARE UNIT AND IT IS VERY CONCERNING. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17140822 ↗
• MalfunctionJun 9, 2023Break; Break

  INCIDENT ONE: THE COVID UNIT AT (B)(6) HOSPITAL, A PART OF THE (B)(6) SYSTEM, HAS BEEN EXPERIENCING PRODUCT ISSUES WITH THE HALYARD N95 MASK 46767. STAFF IS REPORTING THE STRAPS ARE BREAKING WHEN TRYING TO WEAR THE MASKS. THE STAFF ARE GIVEN ONE MASK PER SHIFT BUT SOMETIMES HAVE TO USE TWO-THREE BECAUSE OF BREAKING. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME. THE REPORTER HAS INDICATED THAT NO INJURY OR ILLNESS RESULTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17101726 ↗
• MalfunctionJun 9, 2023Break; Break

  INCIDENT TWO: THE COVID UNIT AT (B)(6) HOSPITAL, A PART OF THE MOSES CONE SYSTEM, HAS BEEN EXPERIENCING PRODUCT ISSUES WITH THE HALYARD N95 MASK 46767. STAFF IS REPORTING THE STRAPS ARE BREAKING WHEN TRYING TO WEAR THE MASKS. THE STAFF ARE GIVEN ONE MASK PER SHIFT BUT SOMETIMES HAVE TO USE TWO-THREE BECAUSE OF BREAKING. THE MASKS ARE USED TO ENTER COVID POSITIVE PATIENT ROOMS. THE MASK BREAKS WERE REPORTED TO HAVE OCCURRED DURING USE. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME. THE REPORTER HAS INDICATED THAT NO INJURY OR ILLNESS RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17101725 ↗
• MalfunctionAug 28, 2018Break; Retraction Problem; Stretched

  WE ARE HAVING AN ISSUE WITH THE DUCKBILL MASK 46767 FROM KIMBERLY-CLARK. THE LOT NUMBER IN QUESTION AM9258B81. THE ELASTIC DOESN'T RETRACT, JUST STRETCHES AND SOMETIMES BREAKS. IT LOOKS LIKE SOME OF THESE MASKS COULD HAVE DRY ROT. THIS WAS IDENTIFIED PRIOR TO USE.

  Patient problems: No Information

  MAUDE report 7822178 ↗