Compliance EndoKit™ CEK-1876Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191506034795), received between Aug 21, 2025 and Aug 21, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 21, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COMPLIANCE ENDOKIT WAS BEING PREPARED FOR A PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION, THE TECHNICIAN RETRIEVED AN ENDO COMPLIANCE KIT AND OBSERVED A WORM-LIKE INSECT, RESEMBLING A MEALWORM, INSIDE THE CLEAR PLASTIC WRAPPING SURROUNDING THE GREEN KIT. THEY CHOSE NOT TO USE THE AFFECTED KIT AND SET IT ASIDE; OUT OF CONCERN FOR POTENTIAL CONTAMINATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER COMPLIANCE ENDOKIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860735 ↗