CARDINAL HEALTH SMA13CCEMZRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10197106788530), received between Apr 22, 2025 and Apr 22, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2025Material Twisted/Bent

  FROM STAFF: C/S PACK BULB SYRINGES FOR INFANT SUCTIONING AT DELIVERY-IS BENT AND DOES NOT WORK-BOTH IN PACK. 3RD C/S NOTED THIS WEEK WHERE BULB SYRINGES PROVIDED NONFUNCTIONAL AND NOT ABLE TO DETECT UNTIL TIME OF USE. FURTHER INSPECTION SHOWS STEM SLIGHTLY BENT THAT PREVENTS ADEQUATE USE. 3RD BULB SYRINGE PACKAGED SEPARATELY OPENED AND USED AND ADEQUATELY WORKS-COMPARED 2 AFTER DELIVERY AND DISCREPANCY NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881306 ↗