| | Class 2 Device Recall Material processing laser machines models: A5 Pro, A10 Pro, and A24 Pro |  |
| Date Initiated by Firm | September 30, 2025 |
| Date Posted | December 31, 2025 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0888-2026 |
| Recall Event ID |
98118 |
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| Product Classification |
Laser cutter - Product Code RFE
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| Product | Material Processing Laser Products |
| Code Information |
N/A |
| FEI Number |
3021692431
|
Recalling Firm/ Manufacturer |
SHENZHEN ATOMSTACK TECHNOLOGIES 3 Baolong 6 Rd Guangdong China
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Manufacturer Reason for Recall | Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3) |
FDA Determined Cause 2 | Radiation Control for Health and Safety Act |
| Action | CAP letter to be sent to customers. |
| Distribution | U.S. |
| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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