Beijing Syntech Laser Diode Laser surgical lasers — Class II medical device recall Z-1488-2018
Ongoing recall by Beijing Syntech Laser Co., Ltd, reported 2018-05-09. The noncompliance is that the certification label was not affixed on the product, with statement "Complies wit
| Recall number | Z-1488-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Beijing Syntech Laser Co., Ltd, Beijing, N/A, China |
| Recall initiated | 2017-07-03 |
| Classified | 2018-05-02 |
| Reported by FDA | 2018-05-09 |
| Quantity | 13 |
| Reason classes | labeling |
Product
Beijing Syntech Laser Diode Laser surgical lasers
Reason for recall
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1488-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.