United StatesOlympus Thunderbeat 5 mm devices in multiple lengths (10 cm, 20 cm, 35 cm, 45 cm) and grip styles (Front‑Actuated Grip Type S/Front‑Actuated Grip, Pistol Grip, Inline Grip) — including models TB‑0545FCS, TB‑0535FCS, TB‑0520FCS, TB‑0545FC, TB‑0535FC, TB‑0520FC, TB‑0545PC, TB‑0535PC, TB‑0545IC, TB‑0535IC, TB‑0520IC, and TB‑0510IC and the listed UDIs and lots — are affected. The firm is initiating a removal because of continued reports of adverse events.
What's being recalled
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip
Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA, United States.
How to identify it
Model No. TB-0545FCS; UDI: 04953170383533, 04953170383526, 04953170409684, 04953170383519; All Lots. Model No. TB-0535FCS; UDI: 04953170383564, 04953170383557, 04953170409677, 04953170383540; All Lots. Model No. TB-0520FCS; UDI: 04953170383571, 0495317083595, 04953170383588; All Lots. Model No. TB-0545FC; UDI: 04953170337543; All Lots. Model No. TB-0535FC; UDI: 04953170337574, 04953170464959; All Lots. Lot Code: Model: TB-0520FC; UDI: 04953170370519, 04953170370502; All Lots. Model No. TB-0545PC; UDI: 04953170308635; All Lots. Model No. TB-0535PC; UDI: 04953170308659; All Lots. Model No. TB-0545IC; UDI: 04953170308673; All Lots. Model No. TB-0535IC; UDI: 04953170464973; All Lots. Model No. TB-0520IC; UDI: 04953170308581, 04953170608710; All Lots. Model No. TB-0510IC; UDI: 04953170308734; All Units.
The hazard
Firm is initiating a removal due to continued reports of adverse events.
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
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
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)