Class II — Quanta System, S.p.A.
| Recalling firm | QUANTA SYSTEM, S.P.A. |
|---|---|
| Registered facility | QUANTA SYSTEM, S.P.A. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Product sterility is potentially compromised. |
| Product | Olympus Sterile Optical Laser Fiber, single use and reusable |
| Quantity | 26925 units |
| Distribution | Nationwide distribution via 6 US distributors |
| Initiated | 2021-04-27 |
| Classified | 2021-06-09 |
| Terminated | 2023-09-05 |
| Recall number | Z-1842-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Quanta System, S.p.A. (Z-1842-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87814/
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