Halyard 69572Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20680651695721), received between Jun 3, 2024 and May 5, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Unsafe to Use in Environment” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Device Unsafe to Use in Environment

  TRACTION STRIPS COMING OFF THE HALYARD BOOT COVERS. ISOLATED TO STERILE PROCESSING DEPARTMENT. NO PATIENTS WERE INVOLVED; ALTHOUGH TWO STAFF MEMBERS HAVE FALLEN. ONE WENT TO THE ER. NO MEDICAL TREATMENT OR ADMISSION WAS REQUIRED. THEY HIT THEIR HEAD AND FELL ON ELBOW.

  Patient problems: Fall

  MAUDE report 25081756 ↗
• MalfunctionApr 22, 2026Device Unsafe to Use in Environment

  THE TRACTION BLACK STRIP ON THE BOTTOM OF THE BOOT COVER WAS REPORTED TO PEEL OFF WHILE STAFF WERE IN THE PATIENT¿S ROOM PERFORMING ROUTINE NURSING CARE. AS A RESULT, THE BOOT COVERS WERE PERCEIVED AS SLIPPERY, SLOWING STAFF MOVEMENT, PARTICULARLY IN HIGH-LEVEL INFECTIOUS DISEASE SETTINGS DUE TO CONCERNS ABOUT POTENTIAL SLIPS OR FALLS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24960936 ↗
• MalfunctionJan 15, 2026Device Unsafe to Use in Environment

  STERILE PROCESSING REPORTED THE FOAM STRIPS ON THE BOTTOM OF THE BOOT COVERS ARE DETACHING AND OCCASIONALLY CREATING A TRIPPING HAZARD IN THE DECONTAMINATION AREA. NO INJURIES OR MEDICAL TREATMENT WAS REPORTED BY USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24083311 ↗
• InjuryJun 3, 2024Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INITIAL COMPLAINT WAS RECEIVED ON OCTOBER 9TH, 2023, INDICATING THERE WAS A CONCERN ABOUT LACK OF TRACTION ON THE SHOE COVERS. THERE WAS NO INJURY OR ADVERSE EFFECTS REPORTED AT THAT TIME, LEADING TO AN INITIAL DETERMINATION THAT THIS WOULD NOT BE REPORTABLE OR LIKELY CAUSE A SERIOUS INJURY SHOULD IT RECUR. OWENS AND MINOR RECEIVED A REQUEST TO RETURN PRODUCT ON MAY 6TH, 2024. DURING THIS COMMUNICATION, IT WAS INDICATED BY THE REPORTER, THAT THERE WAS A "SLIP" THAT HAD OCCURRED. OWENS AND MINOR FOLLOWED UP WITH THE REPORTER TO OBTAIN ADDITIONAL INCIDENT DETAILS. THE REPORTER NOW INDICATES THAT THE SURGICAL ASSISTANT HAD FALLEN AND HURT BACK. NO INTERVENTION OR MEDICAL TREATMENT WAS REQUIRED.

  Patient problems: Fall

  MAUDE report 19451008 ↗