Halyard 69672Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20680651696728), received between Jun 5, 2024 and May 5, 2026 — classified as 1 injury, 3 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 EMERGENCY ROOM. NO MEDICAL TREATMENT OR ADMISSION WAS REQUIRED. THEY HIT THEIR HEAD AND FELL ON ELBOW.

  Patient problems: Fall

  MAUDE report 25080102 ↗
• MalfunctionApr 7, 2026Device Unsafe to Use in Environment

  FOAM STRIPS WERE REPORTED TO DETACH FROM THE BOTTOM OF THE BOOT COVERS DURING USE. NO SLIPS OR FALLS OCCURRED DURING USE, AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. SIMILAR INCIDENTS HAVE PREVIOUSLY RESULTED IN SLIPS AND FALLS; THEREFORE, THIS COMPLAINT IS BEING REPORTED AS A FAILURE WHICH IS LIKELY TO CAUSE A SERIOUS INJURY OR ILLNESS SHOULD IT RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24798431 ↗
• MalfunctionJun 23, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  SURGEON STATES THERE IS MINIMAL GRIP ON THE BOTTOM OF SHOE COVER. THE SURGEON NEEDS GRIP TO REAM IN SOME OF THEIR CASES AND HE IS UNABLE TO DO SO SAFELY WITHOUT SLIDING ON FLOOR. HE HAS SLIPPED/SLID WHILE WEARING THEM. THE TREAD FALLS OFF AND STICKS TO FLOOR INSTEAD OF THE BOOT. SURGEON STATES HE'S ALMOST FALLEN EVEN ON DRY FLOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308931 ↗
• MalfunctionJun 5, 2024Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  THE BOOT COVERS HAVE A BLACK STRIP ON THE BOTTOM THAT COMES OFF. THE STRIP HELPS PREVENT SLIPPING WHILE WALKING IN THE BOOT COVERS. STAFF ARE WORRIED ABOUT POTENTIALLY FALLING AND INJURYING THEMSELVES OR PATIENTS WHILE WEARING THESE IN AN OR SETTING WHERE FLUIDS ARE PRESENT. THERE ARE NO INJURIES REPORTED CURRENTLY BY THE SITE.

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

  MAUDE report 19469310 ↗