Halyard 48050Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651480504), received between Dec 16, 2025 and Dec 16, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Break; Break

  THE CUSTOMER REPORTED AN ISSUE WITH THE ROBOTIC DRAPE WITH ATTACHED LEGGINGS, NOTING THAT THE SEAMS ON THE LEGGINGS ARE COMING APART. CUSTOMER REPORTED NO PATIENT INJURY OR MEDICAL TREATMENT WAS REQUIRED. ADDITIONAL INFORMATION WAS REQUESTED ON (B)(6) 2025, (B)(6) 2025, AND (B)(6) 2025. NO RESPONSES HAVE BEEN RECEIVED TO-DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819112 ↗
• MalfunctionDec 16, 2025Break; Break

  THE CUSTOMER REPORTED AN ISSUE WITH THE ROBOTIC DRAPE WITH ATTACHED LEGGINGS, NOTING THAT THE SEAMS ON THE LEGGINGS ARE COMING APART. CUSTOMER REPORTED NO PATIENT INJURY OR MEDICAL TREATMENT WAS REQUIRED. ADDITIONAL INFORMATION WAS REQUESTED ON (B)(6) 2025, (B)(6) 2025, AND (B)(6) 2025. NO RESPONSES HAVE BEEN RECEIVED TO-DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818199 ↗