Olympus ENDOEYE HD II Video Telescopes — Class II medical device recall Z-0403-2016

Terminated recall by Olympus Corporation of the Americas, reported 2015-12-16, distributed nationwide. A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heat

Recall number	`Z-0403-2016`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Olympus Corporation of the Americas, Center Valley, PA, United States
Recall initiated	2015-11-17
Classified	2015-12-10
Reported by FDA	2015-12-16
Terminated	2017-01-24
Distributed	Nationwide (US)
Quantity	182
Serial numbers	`622483`, `622523`, `622539`, `622540`, `622553`, `622566`, `622568`, `622569`, `622570`, `622572`, `622573`, `622576`, `622614`, `622615`, `622616`, `622617`, `622618`, `622619`, `622620`, `622632`, `622643`, `622644`, `622645`, `622646`, `622647` and 148 more
Model numbers	`WA50040A`

Product

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.

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0403-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.