Olympus Endoeye HD II Video Telescopes Recalled for Overheating Tip
Olympus is recalling 863 Endoeye HD II video telescopes because a damaged temperature sensor can cause the tip to become abnormally hot.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant injury (burns) due to the device becoming abnormally hot, which aligns with the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
Olympus Corporation of the Americas is recalling 863 units of ENDOEYE HD II Video Telescopes, including models WA50040A and WA50042A, as well as repair cable part number W7100603. The recall covers all serial numbers for these specific models.
The recall was initiated because a damaged temperature sensor at the endoscope's tip can cause the distal end of the device to become abnormally hot. This defect presents a risk of thermal injury to patients during use.
The affected devices were distributed nationwide. Healthcare providers and facilities should stop using the affected units and contact Olympus Corporation of the Americas for further instructions on repair or replacement.
The recalled product
- Product
- Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable; repair cable 10mm 0/30 deg., part number W7100603
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopes
- Hazard
- Affected units
- 863
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 (1)
- All serial numbers
Distribution
Distributed nationwide across the United States.
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