Halyard 34151Recalls & reported problems
O&M Halyard, Inc. · QUICK CHECK,H600,STRWRP,-,36X36,72 · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20680651341512), received between Apr 18, 2017 and Jan 28, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Thermal Decomposition of Device” (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.
Reports received per month
Most reported problems
Device problems
- Thermal Decomposition of Device1
Patient problems
- Burn(s)1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2026
IMPERFECTIONS (WEBBING) IN ALL SIZES OF THE HALYARD WRAPS. THIS WEBBING COMPROMISES STEAM PENETRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24200878 ↗InjuryApr 18, 2017Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS REPORTED THAT A PATIENT RECEIVED A BURN FROM A STERILIZATION WRAP IN THE OPERATING ROOM. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Burn(s)
MAUDE report 6499896 ↗
Other Wrap, sterilization devices
- Turbett Surgical TS1500Turbett Surgical Inc · Wrap, Sterilization2 recalls0 reports
- Turbett Surgical TS1000Turbett Surgical Inc · Wrap, Sterilization1 recall0 reports
- Turbett Surgical TS1200Turbett Surgical Inc · Wrap, Sterilization1 recall0 reports
- Halyard 34164O&M Halyard, Inc. · Wrap, sterilization11 reports
- Halyard 34145O&M Halyard, Inc. · Wrap, sterilization5 reports
- Halyard 34147O&M Halyard, Inc. · Wrap, sterilization3 reports
- Halyard 34199O&M Halyard, Inc. · Wrap, sterilization3 reports
- Halyard 34148O&M Halyard, Inc. · Wrap, sterilization3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.