Z-0630-2022 Class II Ongoing
FDA device recall Z-0630-2022 was initiated by Becton Dickinson & Co. on Jan 5, 2022 and is designated Class II. Reason for recall: May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative AC power adapter, and not the one provided by BD is used to power the instrument. The recall status is ongoing. Affected quantity: 126,952 Analyzers Updated:129, 848 Analyzers.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 16, 2022
- Initiation Date
- Jan 5, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 126,952 Analyzers Updated:129, 848 Analyzers
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Armenia, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, Fiji, Guatemala, Hong Kong, Honduras, Haiti, Indonesia, India, Jamaica, Cambodia, South Korea, Macao, Mexico, New Zealand, Panama, Peru, Philippines, Singapore, El Salvador, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Vietnam.
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-0630-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026