Halyard 34183Recalls & reported problems
O&M Halyard, Inc. · QUICK CHECK,H400,STRWRP,-,24X24,120 · Class 2
Data updated Oct 18, 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 20680651341833), received between May 27, 2026 and May 27, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn1
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.
MalfunctionMay 27, 2026Material Split, Cut or Torn
THE CUSTOMER REPORTED THAT HOLES WERE IDENTIFIED IN THE PRODUCT AFTER STERILIZATION IN THE OPERATING ROOM, RESULTING IN A DELAY OF THE PROCEDURE. THE SURGERY WAS NOT CANCELED; HOWEVER, A BREACH OF THE STERILE BARRIER WAS NOTED. INFORMATION WAS RECEIVED ON MARCH 31, 2026, STATING THERE WAS HOLE IN THE WRAP DISCOVERED WHEN OPENING THE BOX. A QUESTIONNAIRE WAS SENT TO THE REPORTER WHO REPLIED ON (B)(6) 2026 WITH FURTHER DETAILS INDICATING THIS WAS DISCOVERED IN THE OPERATING ROOM AND THERE WAS A BREACH IN STERILITY AT WHICH POINT THE NEW DETAILS LED TO CONCLUSION THIS WAS A REPORTABLE MALFUNCTION DUE TO INCREASED LIKELIHOOD THAT RECURRENCE MAY LEAD TO A SERIOUS INJURY OR ILLNESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25304217 ↗
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 34148O&M Halyard, Inc. · Wrap, sterilization3 reports
- Halyard 34147O&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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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