Reported Dec 16, 2015 · Terminated
Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm,…
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-0610
Is this the product you have?
- Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree. The ENDOEYE video Telescopes are used with other supporting equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.
- Lot codes and dates
173 of 173 codes
Serial numbers 622483622523622553622566622568622569622573622576622614622615622616622617622618622619622620622632622643622644622645622646622647622654622655622656622657622658622664622666622667622687622688622693622704622705622706622710622711622712622718622719622720622722622723622750622753622764622766622767622769622771622773622775622777622778622785622789622795622797622798622801
- Amount recalled
- 182
Where it was sold
Why it was recalled
A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could result in patient or user injury.
This product could cause temporary or reversible health problems — stop using it.
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