Halyard 34179Recalls & reported problems
O&M Halyard, Inc. · QUICK CHECK,H500,STRWRP,-,60X60,24 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 20680651341796), received between Feb 16, 2018 and Feb 16, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Hole In Material” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Hole In Material1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2018Hole In Material; Hole In Material
IT WAS REPORTED THAT THERE WAS A HOLE IN THE MATERIAL THAT APPEARED TO LOOK LIKE IT WAS CUT WITH A KNIFE. THE USER IS UNSURE IF THERE MIGHT HAVE BEEN A HOLE IN THE MATERIAL BEFORE SHIPPING. IT WAS FOUND AFTER USE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7277965 ↗
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 34148O&M Halyard, Inc. · Wrap, sterilization3 reports
- Halyard 34199O&M Halyard, Inc. · Wrap, sterilization3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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