Z-2269-2018 Class II Terminated
FDA device recall Z-2269-2018 was initiated by Olympus Corporation Of The Americas on May 11, 2018 and is designated Class II. Reason for recall: Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating to reported patient infections… The recall status is terminated (terminated May 5, 2020). Affected quantity: 994.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 27, 2018
- Initiation Date
- May 11, 2018
- Termination Date
- May 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 994
Product Description
Olympus JF-140F duodenoscopes (Model NumberJF-140F)
Reason for Recall
Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating to reported patient infections associated with duodenoscopes. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning and manual disinfection.
Distribution Pattern
Nationwide
Code Information
All
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2269-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026