SOLTIVE SuperPulsed Laser Fibers — Class II medical device recall Z-1296-2022
Terminated recall by Olympus Corporation of the Americas, reported 2022-07-06, distributed nationwide. Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immedi
| Recall number | Z-1296-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2022-05-26 |
| Classified | 2022-06-28 |
| Reported by FDA | 2022-07-06 |
| Terminated | 2025-02-05 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00821925043923, 00821925043930, 00821925043985, 00821925044043 |
Product
SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX200S (Pouch) - 200 Micron Single Use Fiber Model # Labeled TFL-FBX200BS (Carton) - 200 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX550S (Carton) - 550 Micron Single Use Fiber Model # Labeled TFL-FBX200S (Carton) - 200 Micron Single Use Fiber Model # Labeled TFL-FBX365S (Pouch) - 200 Micron Single Use Fiber
Reason for recall
Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device.
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-1296-2022. 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.