Medical Action Industries 704-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10809160000410), received between Aug 28, 2024 and Oct 17, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Product Quality Problem” (2 reports).

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.

• InjuryOct 17, 2024Product Quality Problem; Product Quality Problem

  AN EVENT OCCURRED ON SEPTEMBER 24, 2024, THAT STATES PRODUCT IS LEAVING LINT ON OPEN WOUNDS. THE DOCTOR REPORTED THAT THE SINGLE-USE OR TOWELS THAT ARE COMING DOWN FROM SPD ARE NOT CLINICALLY ACCEPTABLE AS THEY ARE LEAVING LINT AND DEBRIS IN THE SURGICAL WOUND. THIS INCIDENT MAY NOT BE CAUGHT BY SURGEONS OR STAFF IF THEY ARE NOT USING A MICROSCOPE. THE DOCTOR REPORTED THAT UNDER THE MICROSCOPE IT LOOKS LIKE THE WOUND IS BEING COVERED IN FUR FROM THESE TOWELS. THERE WAS NO DELAY IN SURGERY AND IRRIGATION WAS USED TO WASH OUT THE WOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20474785 ↗
• MalfunctionAug 28, 2024Product Quality Problem; Product Quality Problem

  THE PRODUCT IS SHEDDING AND LEAVING FIBERS ON THE HEPARINIZED SALINE BOWLS AND THE STERILE TABLE. THESE FIBERS GET CAUGHT ON WIRES AND CATHETERS AND CAN POTENTIALLY ENTER THE VESSELS WHERE THE CATHETERS AND WIRES NEED TO GO THROUGH. ADDITIONAL QUESTIONS REGARDING PATIENT IMPACT AND INCIDENT WERE ASKED ON (B)(6) 2024. NO FURTHER DETAILS HAVE BEEN PROVIDED TO-DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20086709 ↗