CARDINAL HEALTH SOP56TK80HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888439420388), received between Feb 26, 2020 and Mar 23, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2020Material Puncture/Hole

  WHILE BRINGING THE DRAPED MAYO STAND INTO THE STERILE FIELD, IT WAS NOTICED THAT THERE WERE LARGE HOLES IN THE DRAPE ALONG THE SIDE OF THE MAYO STAND. THE SURGEON WAS PRESENT AND CONSULTED AND IT WAS DECIDED TO REMOVE THE OUTER GLOVES OF THE SCRUB TECH AND COVER THE HOLES AND ANY AREAS THAT SHE MAY HAVE TOUCHED WITH STERILE IOBAN. THE INNER WRAPPING OF THE PACK WHICH THE MAYO STAND COVER CAME IN WAS SAVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9864863 ↗
• MalfunctionFeb 26, 2020Dull, Blunt

  DULL SCALPEL BLADES IN THE ORTHO TRAY-KIT, UNABLE TO EVEN CUT THROUGH IOBAN SKIN DRAPE ON INITIAL SURGICAL INCISION. THE BLADES WITHIN THE PACK ARE BARD-PARKER RIB-BACK, LOT #0200156. ALL 6 BLADES FROM THIS PACK WERE DULL. ANOTHER PACK WAS OPENED (SAME CATALOG # AND LOT#) THAT HAD AT LEAST 2 DULL BLADES IN THE PACK. SAME LOT # ON ALL BLADES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9753470 ↗