Flexiva Pulse 242 TracTip Single-Use Laser Fibers — Class II medical device recall Z-2229-2023
Ongoing recall by Boston Scientific Corporation, reported 2023-08-02, distributed nationwide. Manufactured with the incorrect component may result in lower power output and degradation or dimming of the a
| Recall number | Z-2229-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2023-05-25 |
| Classified | 2023-07-21 |
| Reported by FDA | 2023-08-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 339 units |
| Reason classes | specification failure, device malfunction |
| UPC / GTIN / UDI-DI | 08714729978619 |
| Lot numbers | 30389365, 30389368, 30389369, 30429826, 30479399, 30479580, 30479582, 30554453 |
| Expiration dates | 2025-10-20 |
Product
Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN : M006L8405960
Reason for recall
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
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-2229-2023. 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.