CARDINAL HEALTH SOP12KNMFMRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10197106405864), received between Aug 19, 2025 and Jan 27, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.

• MalfunctionJan 27, 2026

  DURING OPENING OF STERILE FIELD, IT WAS NOTED THE STERILE SUPPLY PACK HAD MULTIPLE AREAS THAT LOOKED LIKE PIERCINGS THROUGH THE INTERNAL WRAP LAYER. THERE WERE AREAS OF DISTRESS ON THE OUTER LAYER, BUT NO AREAS SHOWED PIERCING OR TEARING. NEW SUPPLY PACK WAS OBTAINED. ITEM: SOP12KNMFM, EXP: 07/01/2027, LOT: 638489.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188099 ↗
• MalfunctionAug 19, 2025Contamination /Decontamination Problem; Device Fell

  DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE WHILE IMPLANTS WERE BEING PLACED, A LIGHT HANDLE COVER FELL FROM ONE OF THE WORKING OVERHEAD LIGHTS INTO THE STERILE FIELD. LIGHT HANDLE COVER WAS REMOVED FROM THE FILED AND REPLACED WITH A NEW COVER. SURGEON AWARE ACKNOWLEDGED. IRRIGATED WOUND PRIOR TO CLOSURE. WOUND CLASS CHANGED TO CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22839894 ↗