Halyard 69254Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 20680651692546), received between Sep 14, 2023 and Sep 17, 2025 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Unsafe to Use in Environment” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  ONE OF THE STAFF MEMBERS SLIPPED AND FELL IN THE AUTOPSY ROOM. THE SHOE COVER DOES NOT PROVIDE SUFFICIENT SKID RESISTANCE. THERE WAS NO INJURY OR MEDICAL TREATMENT REQUIRED DUE TO FALL.

  Patient problems: Fall

  MAUDE report 23076274 ↗
• MalfunctionAug 8, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  THE CUSTOMER HAS REPORTED A POTENTIAL SAFETY CONCERN INVOLVING THE USE OF SHOE COVERS. SPECIFICALLY, THEY INDICATED THAT THE COVERS ARE SLIPPERY. AS A RESULT, ONE EMPLOYEE EXPERIENCED A NEAR-FALL INCIDENT WHICH CAUSED MINOR BACK STRAIN. NO SERIOUS INJURY HAS BEEN REPORTED AT THIS TIME. FOLLOW-UP QUESTIONS WERE SUBMITTED TO THE CUSTOMER TO GATHER ADDITIONAL DETAILS REGARDING THE INCIDENT. AS OF THE DATE OF THIS REPORT, NO RESPONSES HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749947 ↗
• MalfunctionFeb 18, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  THE OPERATING ROOM REPORTED "SLIPPAGE" WHILE WEARING THE SHOE COVERS. THERE WAS NO INJURY REPORTED AT TIME OF COMPLAINT RECEIPT. ADDITIONAL FOLLOW UP QUESTIONNAIRE WAS SENT TO CUSTOMER ON FEBRUARY 3, 6, AND 10TH TO ACQUIRE ADDITIONAL DETAILS. NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21398615 ↗
• InjuryFeb 18, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  A SAFETY EVENT SLIP/FALL OCCURRED WHILE WEARING THE SHOE COVERS. THE CUSTOMER ALLEGED THIS INCIDENT WAS DUE TO PLACING TOO MUCH WEIGHT ON THE HEEL OF THE SHOE COVER. A QUESTIONNAIRE WAS SENT TO CUSTOMER ON FEBRUARY 6, 10, AND 13TH TO ACQUIRE MORE DETAILS ABOUT REPORTED INCIDENT. NO RESPONSE HAS BEEN RECEIVED YET.

  Patient problems: Fall

  MAUDE report 21397688 ↗
• MalfunctionJan 24, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT TWO (B)(6) HOSPITAL HAS HAD SEVERAL FALLS IN THEIR L&D AREA. CUSTOMER SUSPECTS IT COULD HAVE SOMETHING TO DO WITH RESIDUAL POWDER OR SOMETHING COMING OFF THE SHOE COVERS. ADDITIONAL INFORMATION WAS REQUESTED ON JANUARY 14, 2025, JANUARY 15, 2025, AND JANUARY 16, 2025, WITH NO RESPONSE RECEIVED BACK FROM THE CUSTOMER. BASED ON COMPLAINT REPORT WITH MINIMAL INFORMATION, AT THIS TIME IT'S UNKNOWN IF THERE WERE ANY SERIOUS INJURIES OR MEDICAL INTERVENTION REQUIRED DUE TO REPORTED FALLS. THE CUSTOMER ALSO DID NOT PROVIDE A LOT NUMBER.

  Patient problems: Fall

  MAUDE report 21233160 ↗
• MalfunctionJan 24, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT ONE (B)(6) HOSPITAL HAS HAD SEVERAL FALLS IN THEIR L&D AREA. CUSTOMER SUSPECTS IT COULD HAVE SOMETHING TO DO WITH RESIDUAL POWDER OR SOMETHING COMING OFF THE SHOE COVERS. ADDITIONAL INFORMATION WAS REQUESTED ON JANUARY 14, 2025, JANUARY 15, 2025, AND JANUARY 16, 2025, WITH NO RESPONSE RECEIVED BACK FROM THE CUSTOMER. BASED ON COMPLAINT REPORT WITH MINIMAL INFORMATION, AT THIS TIME IT'S UNKNOWN IF THERE WERE ANY SERIOUS INJURIES OR MEDICAL INTERVENTION REQUIRED DUE TO REPORTED FALLS. THE CUSTOMER ALSO DID NOT PROVIDE A LOT NUMBER.

  Patient problems: Fall

  MAUDE report 21233118 ↗
• InjuryDec 12, 2024Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  COMPLAINT WAS RECEIVED ON NOVEMBER 18, 2024, INDICATING SHOE COVERS ARE SLIPPERY. ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 22, 2024. A SURGICAL TECHNICIAN WAS WALKING IN THE OR, TO CLEAN UP AFTER THE CASE WAS COMPLETE, WHEN THEY SLIPPED, FELL, AND HIT THEIR HEAD. THE DATE OF THE EVENT WAS OCTOBER 28, 2024. THE EMPLOYEE SUFFERED A CONCUSSION AND REQUIRED TREATMENT. THE EMPLOYEE IS STABLE, AND APPROPRIATE REPORTING HAS BEEN COMPLETED.

  Patient problems: Fall

  MAUDE report 20921279 ↗
• MalfunctionOct 17, 2024Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT TWO: THERE WERE 2 WORKPLACE INJURIES REPORTED. THE CUSTOMER REPORTED THE TRACTION WAS INSUFFICIENT. THESE WERE NOT SERIOUS INJURIES; NO MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO LOST TIME FROM WORK, ONLY BRUISING.

  Patient problems: Fall

  MAUDE report 20475442 ↗
• MalfunctionOct 17, 2024Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  INCIDENT ONE. THERE WERE 2 WORKPLACE INJURIES REPORTED. THE CUSTOMER REPORTED THE TRACTION WAS INSUFFICIENT. THESE WERE NOT SERIOUS INJURIES; NO MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO LOST TIME FROM WORK, ONLY BRUISING.

  Patient problems: Fall

  MAUDE report 20474939 ↗
• MalfunctionApr 10, 2024Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  THE PROVIDER WAS WEARING SHOE COVER OUTSIDE OF THE OPERATING ROOM AND SLIPPED. THE PROVIDER DID NOT REPORT FALLING AND THERE WAS NO INJURY TO THE PROVIDER AS A RESULT OF SLIPPING WEARING THE SHOE COVER. THE PROVIDER NOTED POOR TRACTION AND DESIGN OF THE PRODUCT.

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

  MAUDE report 19079230 ↗
• InjurySep 14, 2023Device Slipped; Device Slipped

  THE GRIP TAPE ON THE BOTTOM OF THE COVERS IS SMOOTH AND NOT TACKY. STAFF MEMBER SLIPPED ON A TEXTURED RAMP WHILE WEARING THESE COVERS AND WAS INJURED. ADDITIONAL DETAILS REGARDING INJURY WERE REQUESTED ON AUGUST 18 AND AUGUST 23, 2023. NO RESPONSE HAS BEEN RECEIVED TO-DATE.

  Patient problems: Fall

  MAUDE report 17743922 ↗