CLASS II ONGOING Device recall · Reported 29 Nov 2023 · FDA Enforcement Report
Signmoidovideoscope-For endoscopy recalled by Aizu Olympus Co
Aizu Olympus Co is recalling Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract, distributed nationwide in the US. The recall was initiated on 25 Sep 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0342-2024
- FDA event ID
- 93222
- Recalling firm
- Aizu Olympus Co, Aizuwakamatsu, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Sep 2023
- FDA classified
- 17 Nov 2023
- Reported
- 29 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Surgical Instruments
Timeline
| 25 Sep 2023 | Recall initiated by company | |
| 17 Nov 2023 | Classified by FDA | +53 days |
| 29 Nov 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Number: PCF-S.
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Is Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract recalled?
Yes. Aizu Olympus Co recalled Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract on 25 Sep 2023. The recall is Class II and its status is Ongoing. Recall number Z-0342-2024.
Why was it recalled?
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
Which lots are affected?
Model Number (UDI-DI): PCF-S (04953170339912).
Where was it sold?
Worldwide - US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Aizu Olympus Co
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Olympus OER-Mini recalled by Aizu Olympus Co | Aizu Olympus Co | Other | Nationwide |
| Device | CLASS II | Olympus OER-Pro recalled by Aizu Olympus Co | Aizu Olympus Co | Other | Nationwide |
| Device | CLASS II | Olympus OER-Elite recalled by Aizu Olympus Co | Aizu Olympus Co | Other | Nationwide |
| Device | CLASS II | Gif-hq190, Evis Exera Iii Gastrointestinal Videoscope recalled | Aizu Olympus Co | Lead & Heavy Metals | 6 states |
| Device | CLASS II | Gif-h190, Evis Exera Iii Gastrointestinal Videoscope recalled | Aizu Olympus Co | Lead & Heavy Metals | 6 states |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |