Olympus Thunderbeat 5 mm 35 cm Inline Grip Medical Device Recall
Olympus Corporation of the Americas is recalling Olympus Thunderbeat 5 mm, 35 cm, Inline Grip devices due to reports of adverse events.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The product is a medical device with reported adverse events, and the FDA has classified this as a Class II recall.
Plain-English summary
Olympus Corporation of the Americas is initiating a removal of the Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip (Model No. TB-0535IC; UDI: 04953170464973; All Lots).
This action is being taken due to continued reports of adverse events associated with the device.
This recall affects 52 units distributed worldwide, including the United States, Brazil, Canada, Germany, Mexico, and Japan.
The recalled product
- Product
- Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 52
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. TB-0535IC
- UDI: 04953170464973
- All Lots.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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