Quanta System Sterile Optical Laser Fiber — Class II medical device recall Z-1843-2021
Terminated recall by Quanta System, S.p.A., reported 2021-06-16, distributed nationwide. Product sterility is potentially compromised.
| Recall number | Z-1843-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Quanta System, S.p.A., Samarate, N/A, Italy |
| Recall initiated | 2021-04-27 |
| Classified | 2021-06-09 |
| Reported by FDA | 2021-06-16 |
| Terminated | 2023-09-05 |
| Distributed | Nationwide (US) |
| Quantity | 2,427 units |
| Reason classes | sterility |
| Lot numbers | A180300, A183626, A184635, A190301, A190302, A190303, A192113, A192114, A192115, A192906, A192908, A192911, A192914, A193102, A193106, A193108, A193110, A193111, A193112, A193113, A193613, A193616, A194108, A194207, A194208, A194209, A194210, A194211, A194527, A194528, A194529, A194532, A195013, A195014, A201001, A201002, A202027, A202028, A202029, A380350 and 11 more |
| Model numbers | A183626, A184635, A192114, A193106, A193613, A194207, A194208, A194527, A194528, A194529, A201001, A201002, A202027, OAF002011, OAF005511, OAF006001, OAF008001 |
Product
Quanta System Sterile Optical Laser Fiber, single use
Reason for recall
Product sterility is potentially compromised.
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-1843-2021. 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.