Summary
The FDA issued a Class II for Material Processing Laser Products by SHENZHEN ATOMSTACK TECHNOLOGIES. Reason: Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3).
Details
Source
Device Recall
External ID
Z-0888-2026
Action Date
2026-01-07
Status
Ongoing
Category
device
Product Description
Material Processing Laser Products
Lot/Code Info: N/A
Quantity Affected: N/A
Reason for Recall
Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3)
Distribution
U.S.
Type: FDA Mandated
Recall Initiated: 2025-09-30
Company
Guangdong, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 85 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SHENZHEN ATOMSTACK TECHNOLOGIES) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SHENZHEN ATOMSTACK TECHNOLOGIES have FDA actions?
This is the only FDA action we have on record for SHENZHEN ATOMSTACK TECHNOLOGIES in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0888-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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