Z-1080-2022 Class II Ongoing
FDA device recall Z-1080-2022 was initiated by Boston Scientific Corporation on Mar 3, 2022 and is designated Class II. Reason for recall: Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal… The recall status is ongoing. Affected quantity: 6,946 units. US: 6,916; OUS: 30.
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2022
- Initiation Date
- Mar 3, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,946 units. US: 6,916; OUS: 30
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, IRELAND, Israel, Italy, Kuwait, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Unit. Arab Emir.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1080-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026