The Recall Desk
HighFDA (Devices)·Z-0329-2024·Announced 2023-11-29

Colonoscopes Recalled for Unvalidated Channel Drying Process and Infection Risk

Aizu Olympus is recalling certain colonoscope models because the channel air drying process was not validated. A small percentage of repaired units had water remaining in the channel, which could lead to infection risk.

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: FDA Class II device with theoretical risk of infection from water contamination. No illnesses or injuries have been reported, meeting the rubric criterion for 'High' severity as a risk-of-harm product without reported injury.

Plain-English summary

Aizu Olympus Co., Ltd. is recalling 3344 colonoscopes worldwide because the channel air drying process was not properly validated. A small percentage of colonoscopes returned to customers after repair had water remaining in the channel.

Water remaining in the channel of the endoscope creates a potential risk of contamination that could lead to infection during endoscopic procedures.

Healthcare facilities using affected colonoscope models should contact Aizu Olympus Co., Ltd. regarding this recall.

The recalled product

Product
Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-
Manufacturer
Aizu Olympus Co., Ltd.
Category
Medical Device — Endoscopy Equipment
Hazard
  • water-contamination
  • infection-risk

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 (19)

  • Model Number (UDI-DI): CF-2T160I (04953170307645)
  • CF-2T160L (04953170307652)
  • CF-H170I (04953170334184)
  • CF-H170L (04953170334160)
  • CF-H180AI (04953170339585)
  • CF-H180AL (04953170339608)
  • CF-H180DI (04953170339639)
  • CF-H180DL (04953170339653)
  • CF-H190I (04953170305177)
  • CF-H190L (04953170305153)
  • CF-HQ190I (04953170305139)
  • CF-HQ190L (04953170305115)
  • CF-LV1I (04953170312410)
  • CF-LV1L (04953170312397)
  • CF-Q150I (04953170307621)
  • CF-Q150L (04953170307638)
  • CF-Q160S (04953170307669)
  • CF-Q180AI (04953170307690)
  • CF-Q180AL (04953170307706).

Distribution

Distributed nationwide across the United States.

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