United StatesOlympus OER‑Elite, OER‑Pro, and OER‑Mini devices (all serial numbers) distributed nationwide in the U.S.; UDIs: OER‑Elite 04953170404047, OER‑Pro 04953170258589, OER‑Mini 04953170331619. The recall was issued so the firm can inform affected device customers about pertinent warnings/cautions, existing recommended maintenance schedules, and that only properly trained personnel should conduct repairs and maintenance. Owners should follow those warnings and maintenance schedules and ensure only properly trained personnel perform repairs and maintenance.
What's being recalled
Olympus OER-Elite
Olympus OER-Pro
Olympus OER-Mini
Recalling firm: Aizu Olympus Co., Ltd., Aizuwakamatsu, Japan.
How to identify it
Model: OER-Elite; UDI: 04953170404047; Serial #: All; Model: OER-Pro; UDI: 04953170258589; Serial #: All; Model: OER-Mini; UDI: 04953170331619; Serial #: All;
The hazard
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)