MoXy Laser Fiber — Class II medical device recall Z-1798-2020
Terminated recall by Boston Scientific Corporation, reported 2020-05-06, distributed nationwide. To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will
| Recall number | Z-1798-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2020-03-30 |
| Classified | 2020-04-24 |
| Reported by FDA | 2020-05-06 |
| Terminated | 2023-04-05 |
| Distributed | Nationwide (US) |
| Quantity | 146,633 |
| Reason classes | device malfunction |
| Lot numbers | 102, 103, 110, 119, 120932, 126934, 12908, 133, 140183, 1423, 142927, 142932, 1441, 1499, 161, 164690, 16596, 166, 167998, 169, 16916, 1885, 1972, 199218, 21857621, 21857622, 21885134, 21911808, 21918152, 21933082, 21955208, 21966592, 21972810, 22012232, 22012233, 22045291, 22045292, 22075867, 22075868, 22102605 and 460 more |
Product
MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
Reason for recall
To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the likelihood of metal cap and fiber tip break temperature related complaints.
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-1798-2020. 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.