Halyard 68248Recalls & reported problems
O&M Halyard, Inc. · HALYARD,H400,STRWRP,-,48X48,50 · Class 2
Data updated Oct 13, 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 20680651682486), received between Oct 10, 2018 and Oct 10, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (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.
Most reported problems
Device problems
- Material Puncture/Hole1
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.
MalfunctionOct 10, 2018Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THERE WERE TWO HOLES ON THE MIDDLE AND THE EDGE OF THE WRAP. AFTER SURGERY, THE CUSTOMER NOTICED THIS ISSUE. THE CUSTOMER STATED THAT THEY ARE NOT SURE IF THE HOLES WERE OPENED BEFORE USE OR AFTER USE. ADDITIONAL INFORMATION WAS RECEIVED 18-SEPT-2018 THAT STATES, AN EMAIL WAS RECEIVED, HOLE WAS NOTICED POST STERILIZATION. ADDITIONAL INFORMATION WAS RECEIVED 19-SEPT-2018 THAT STATES, THE CUSTOMER FOUND HOLES AFTER SURGERY. HOWEVER, THEY WERE NOT SURE IF THE HOLE OPENED UP BEFORE STERILIZATION. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED 25-SEPT-2018 THAT STATES THERE WERE NO PROBLEM WITH THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7950970 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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