Olympus Sterile Optical Laser Fiber — Class II medical device recall Z-1842-2021
Terminated recall by Quanta System, S.p.A., reported 2021-06-16, distributed nationwide. Product sterility is potentially compromised.
| Recall number | Z-1842-2021 |
|---|---|
| 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 | 26,925 units |
| Reason classes | sterility |
| Lot numbers | H181600, H181601, H181602, H182001, H182002, H182003, H182004, H182009, H182010, H182011, H182012, H182604, H182605, H182606, H182607, H182608, H182609, H182701, H182702, H182703, H182704, H182709, H183616, H183618, H183619, H183620, H183621, H183622, H183919, H183920, H183921, H183922, H183923, H183924, H184001, H184002, H184003, H184004, H184005, H184006 and 239 more |
| Model numbers | H181600, H181601, H181602, H182001, H182002, H182003, H182004, H182009, H182010, H182011, H182012, H182604, H182605, H182606, H182607, H182608, H182609, H182701, H182702, H182703, H182704, H182709, H183616, H183618, H183919 and 247 more |
Product
Olympus Sterile Optical Laser Fiber, single use and reusable
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-1842-2021. 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.