FDA Enforcement
Class II
Ongoing
Material Processing Laser Products
Recall: Z-0888-2026
·
Reported January 7, 2026
Enforcement
- Recall Number
- Z-0888-2026
- Event ID
- 98118
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- SHENZHEN ATOMSTACK TECHNOLOGIES
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- N/A
- Report Date
- January 7, 2026
- Initiation Date
- September 30, 2025
- Classification Date
- December 31, 2025
- Address
- 3 Baolong 6 Rd, N/A, Guangdong, N/A, N/A, China
Description
Material Processing Laser Products
Reason
Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3)
Code Info
N/A
Distribution
U.S.
Quantity
N/A