The Recall Desk
HighFDA (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.

What this means for you

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 w
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Endoscopic Instruments
Hazard
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:

Related recalls

Same manufacturer · Olympus Corporation of the Americas

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Same hazard · burn injury

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