Hytec Probe Cleaning Solution 288197Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816879022315), received between Oct 25, 2017 and Oct 25, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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.

• InjuryOct 25, 2017Device Markings/Labelling Problem

  THE CUSTOMER REPORTED A POTENTIAL ISSUE WITH THE HYTEC DI (DIRECTIONAL INSERT). THE ALLEGED ISSUE INDICATED THE DI "DOES NOT PROVIDE CLEAR INSTRUCTIONS FOR COLLECTING THE CLEANING SOLUTION OR PROVIDE A CONTAINER." HYCOR OPTED TO REPORT THIS EVENT CONSERVATIVELY ON BASIS OF POTENTIAL FOR HARM.

  Patient problems: Discomfort; Dizziness; Nausea

  MAUDE report 6978069 ↗