ORI SF-4XL-ELBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06975085708742), received between Dec 19, 2025 and Dec 19, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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.

• MalfunctionDec 19, 2025Component Missing; Component Missing

  ONE SOLOFIT GOWN WHICH WAS RECENTLY MANUFACTURED LOT 2406E499 (JUNE 2024) WAS OPENED AND USED IN SURGERY, A SALES REPRESENTATIVE OF MANUFACTURER'S DISTRIBUTOR WAS THERE AND NOTICED THAT ONE OF THE SURGICAL GOWNS WAS MISSING A VELCRO STRAP ON THE SHOULDER OF THE GOWN AFTER THE SURGERY WAS COMPLETED. THIS ISSUE COULD RESULT IN THE GOWN NOT MEETING ITS INTENDED USE TO PROTECT AND PROVIDE A BARRIER FOR SURGICAL PERSONNEL TO BE PROTECTED AGAINST CONTAMINATION AND/OR EXPOSURE OF INFECTIOUS BODILY FLUIDS AND HARMFUL MICROORGANISMS. IF VELCRO IS MISSING, THEN IT IS POSSIBLE THAT THE GOWN COULD LOOSEN AND MIGHT INTERRUPT USER IN MIDDLE OF SURGICAL PROCEDURE IF THE SURGICAL GOWN FALLS OFF OR DOWN THE USER'S SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23856499 ↗