Agency classClass IIOur severity:High FDA (Devices)·Z-0403-2016·Announced 2015-12-16

Olympus ENDOEYE HD II Video Telescopes Recalled Due to Overheating Tip

Olympus is recalling 182 ENDOEYE HD II video telescopes because a damaged temperature sensor can cause the tip to overheat, posing a burn risk to patients and users.

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 recall involves a risk-of-harm product (potential burn injury) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Olympus Corporation of the Americas is recalling 182 units of the ENDOEYE HD II Video Telescopes, including models WA50040A, WA50042A, and the W7100603 repair cable. These devices are used with supporting equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including the female reproductive organs.

The recall was initiated because a damaged temperature sensor at the ENDOEYE tip can cause the distal end to become abnormally hot. This excessive heating presents a risk of injury to patients or users during procedures.

The affected units were distributed nationwide in the United States, including in states such as NE, IL, FL, TX, OH, PA, IN, CA, NY, AL, ND, GA, AK, MI, WA, MS, NJ, IA, AZ, and RI. Users should stop using the affected telescopes and contact Olympus Corporation of the Americas for instructions on how to proceed.

The recalled product

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…
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Endoscopic Instruments
Hazard: burn-injury
overheating
Affected units: 182

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 (20)

Serial numbers 622483
622523
622553
622566
622568
622569
622573
622576
622614
622615
622616
622617
622618
622619
622620
622632
622643
622644
622645
622646

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically:

Same manufacturer · Olympus Corporation of the Americas

See all →

Moderate
Olympus DisplayPort Cable Recalled for Video Dropout Risk
FDA (Devices) · 2026-10-07
Moderate
Olympus M3 Gold Autoclavable Foroblique Telescope Recalled for Sterilization Labeling Discrepancy
FDA (Devices) · 2026-10-07
Moderate
Olympus M3 Gold Autoclavable Lateral Telescope 70 Recalled for Sterilization Labeling Discrepancies
FDA (Devices) · 2026-10-07
Moderate
Olympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label
FDA (Devices) · 2026-09-30
Severe
Olympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30

Same hazard · burn injury