CARDINAL HEALTH SBA12LPMFMRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10197106786055), received between Mar 7, 2025 and Jun 9, 2025 — classified as 2 malfunctions.

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

• MalfunctionJun 9, 2025Material Twisted/Bent

  WHILE OPENING SUPPLIES FOR A SURGICAL CASE THE TEAM NOTED THAT TWO DIFFERENT BASIC PACKS THAT WHERE OPENED HAD BENT SUCTION TIPS. DEVICE WAS USED DESPITE THE BEND. REACHED PATIENT. NO HARM. FOR BOTH BASIC PACKS: CARDINAL HEALTH, REF # SBA12LPMFM, LOT# 401900, EXP DATE: 9/1/27.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166195 ↗
• MalfunctionMar 7, 2025

  SURGICAL PACK WAS OPENED IN STERILE MANNER. SUCTION HANDLE WAS FOUND TO BE DEFORMED AND UNUSABLE. ITEM WAS REMOVED FROM STERILE FIELD AND REPLACEMENT WAS PROVIDED. SUPERVISOR AND MATERIALS MANAGEMENT NOTIFIED. PACK INFORMATION: BASIC SET-UP PACK. LOT #: 401900. EXP.: [REDACTED DATE].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21545881 ↗