Halyard 34159Recalls & reported problems
O&M Halyard, Inc. · QUICK CHECK,H300,STRWRP,-,45X45,48 · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20680651341598), received between Feb 24, 2026 and Feb 24, 2026 — classified as 1 malfunction.
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
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2026Appropriate Device Problem Term/Code Not Available
DURING AN ORTHOPEDIC PROCEDURE, A HOLE WAS REPORTED IN THE PRODUCT, RESULTING IN A ONE-HOUR DELAY OF THE SURGERY. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24428293 ↗
Other Wrap, sterilization devices
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- 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.