Halyard 69455Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20680651694557), received between Feb 19, 2026 and Feb 19, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Incompatible” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Component Incompatible

  ON (B)(6), A STAFF MEMBER EXPERIENCED STRIKETHROUGH ON THE FOREARM THAT RESULTED IN A CHEMICAL BURN. THE EMPLOYEE WASHED THE AFFECTED AREA WITH MILD SOAP AND WATER AND COMPLETED THE REMAINDER OF THE SHIFT. THE INCIDENT WAS REPORTED TO EMPLOYEE HEALTH; HOWEVER, TO THE MANAGER¿S KNOWLEDGE, THE EMPLOYEE WAS NOT PRESCRIBED ANY ADDITIONAL TREATMENT OR FURTHER EVALUATION. THE EMPLOYEE RETURNED TO WORK ON (B)(6) WITH NO MEDICAL TREATMENT REPORTED. AT THE TIME OF THE INCIDENT, THE EMPLOYEE WAS WEARING MEDLINE GLOVES. THE BURN OCCURRED ABOVE THE GLOVE LINE. IT IS CURRENTLY UNCLEAR WHETHER THE REACTION WAS CAUSED BY THE CHEMICAL IN USE, THE GOWN SLEEVE, OR THE GLOVES. THE EMPLOYEE IS KNOWN TO HAVE A GENERAL ALLERGY SENSITIVITY. THE CHEMICAL BEING USED AT THE TIME OF THE OCCURRENCE WAS ECOLAB MULTI-ENZYMATIC CONCENTRATED DETERGENT. THE MANAGER STATED THE FACILITY HAS USED THE SAME GOWN STYLE FOR MORE THAN EIGHT YEARS. STAFF MEMBERS CHANGE GOWNS THREE TIMES DURING AN EIGHT-HOUR SHIF; TWICE FOR 15-MINUTE BREAKS AND ONCE FOR A LUNCH BREAK. EMPLOYEES IN THIS AREA ARE ROUTINELY EXPOSED TO HEAVY FLUID LEVELS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24394019 ↗