Medical Action Industries ORT400Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 50809160000715), received between Apr 8, 2019 and Apr 8, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryApr 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  RECEIVED CUSTOMER COMPLAINT FROM DISTRIBUTOR REGARDING EVENT WHEREBY OR TOWEL PRODUCED LINT INTO SURGICAL SITE DURING AN UNIDENTIFIED PROCEDURE. PER DISTRIBUTOR, AFTER MULTIPLE GOOD-FAITH ATTEMPTS, THE END-USER REMAINS UNABLE OR UNWILLING TO PROVIDE ADDITIONAL INFORMATION REGARDING THE ALLEGED EVENT IN ORDER TO CONTRIBUTE TO FURTHER COMPLAINT INVESTIGATION. THERE ARE NO OTHER DETAILS OBTAINED AS CORRESPONDS TO THE REPORT. THE COMPLAINT ITEM IS REFERENCE NUMBER (B)(4), OR TOWEL (NON-XRAY DETECTABLE), MEDICAL ACTION INDUSTRIES BRANDED. THE COMPLAINT LOT WAS NOT REPORTED OR OBTAINED FROM END-USER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8493560 ↗