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FDA Medical Device Recalls (openFDA)

SHENZHEN ATOMSTACK TECHNOLOGIES: Material Processing Laser Products

Recall number
Z-0888-2026
Recalling firm
SHENZHEN ATOMSTACK TECHNOLOGIES
Product
Material Processing Laser Products
Status
Open, Classified
Initiated
2025-09-30
Posted
2025-12-31
Terminated
not on file
Reason
Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3)
Root cause
Radiation Control for Health and Safety Act
Action
CAP letter to be sent to customers.
Quantity
not on file
Distribution
U.S.
Lot, serial or model codes
N/A
510(k) numbers
not on file
PMA numbers
not on file
Product code
RFE
Firm FEI
3021692431
Firm city
not on file
Firm state
Guangdong
Firm country
China

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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