CLASS II ONGOING Device recall · Reported 7 Jan 2026 · FDA Enforcement Report
Material Processing Laser Products recalled by Shenzhen Atomstack
Shenzhen Atomstack Technologies is recalling Material Processing Laser Products. The recall was initiated on 30 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0888-2026
- FDA event ID
- 98118
- Recalling firm
- Shenzhen Atomstack Technologies, Guangdong, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Sep 2025
- FDA classified
- 31 Dec 2025
- Reported
- 7 Jan 2026
- Type
- FDA Mandated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 Sep 2025 | Recall initiated by company | |
| 31 Dec 2025 | Classified by FDA | +92 days |
| 7 Jan 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3)
Product as listed by the FDA
Material Processing Laser Products
Where it was distributed
U.S.
Questions about this recall
Why was it recalled?
Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3)
Which lots are affected?
N/A
Where was it sold?
U.S.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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