Aizu Olympus Co., Ltd. 2023-11-29 Health serious FDA
Health · FDA · Recall #FDA-Z-0342-2024
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract… Recall
Issued November 29, 2023 · Aizu Olympus Co., Ltd.
In November 2023, Aizu Olympus Co., Ltd. recalled the Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
What you should do
- 1 Stop using Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Aizu Olympus Co., Ltd. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Aizu Olympus Co., Ltd.
- Category
- Health
- Recall date
- November 29, 2023
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution.
- Recall number
- FDA-Z-0342-2024
- Made in
- Japan
- Issuing agency
- FDA
In context
- Aizu Olympus Co., Ltd. has 4 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.