Z-1008-2019 Class II Terminated
FDA device recall Z-1008-2019 was initiated by Olympus Corporation Of The Americas on Dec 17, 2018 and is designated Class II. 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… The recall status is terminated (terminated Nov 18, 2020). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 20, 2019
- Initiation Date
- Dec 17, 2018
- Termination Date
- Nov 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
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.
Distribution Pattern
US Nationwide distribution in the states of CT, IL, MN, MO, and NC.
Code Information
Serial Number 2418319
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1008-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026