CLASS II Device recall · Reported 20 Mar 2019 · FDA Enforcement Report
Olympus GF-UCT180 Ultrasound Gastrovideoscope recalled
Olympus Corporation of the Americas is recalling Olympus GF-UCT180 Ultrasound Gastrovideoscope, distributed nationwide in the US. The recall was initiated on 17 Dec 2018 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-1007-2019
- FDA event ID
- 82099
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Dec 2018
- FDA classified
- 12 Mar 2019
- Reported
- 20 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 17 Dec 2018 | Recall initiated by company | |
| 12 Mar 2019 | Classified by FDA | +85 days |
| 20 Mar 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.
Product as listed by the FDA
Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Where it was distributed
US Nationwide distribution in the states of CT, IL, MN, MO, and NC.
Nationwide ConnecticutIllinoisMinnesotaMissouriNorth Carolina
Questions about this recall
Is Olympus GF-UCT180 Ultrasound Gastrovideoscope recalled?
Yes. Olympus Corporation of the Americas recalled Olympus GF-UCT180 Ultrasound Gastrovideoscope on 17 Dec 2018. The recall is Class II and its status is Terminated. Recall number Z-1007-2019.
Why was it recalled?
The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.
Which lots are affected?
Serial Number 7621683
Where was it sold?
US Nationwide distribution in the states of CT, IL, MN, MO, and NC.
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.
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