SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S — Class II medical device recall Z-0748-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2024-01-24, distributed nationwide. Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber clea
| Recall number | Z-0748-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2023-12-01 |
| Classified | 2024-01-18 |
| Reported by FDA | 2024-01-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, HK, JP, SG |
| Quantity | 82,200 units |
| Reason classes | foreign material, device malfunction |
| UPC / GTIN / UDI-DI | 00821925043879, 00821925043916, 00821925043930, 00821925043978, 00821925043992, 00821925044036, 00821925044074 |
| Model numbers | 00821925043879, 00821925043916, 00821925043930, 00821925043978, 00821925043992, 00821925044036, 00821925044074, TFL-FBX150BS, TFL-FBX150S, TFL-FBX200BS, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S |
Product
SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS
Reason for recall
Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to break during use, which may cause burns, procedure delays, prolonged surgery, and foreign body in patient.
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-0748-2024. 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.