FDA Device recall Z-1922-2025
Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FBX150…
- FDA Device
- Class II
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class II recall of Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FBX150… by Olympus, citing potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1922-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-06 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | US |
Product
Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TLF-FBX940S, TFL-FBX150BS-JA (Japan Only), TFL-FBX550S-JA (Japan Only), TFL-FBX940S-JA (Japan Only), TFL-FBX200BS-JA (Japan Only), TFL-FBX150S-JA (Japan Only), TFL-FBX200S-JA (Japan Only), TFL-FBX365S-JA (Japan Only); Product Description: SOLTIVE Laser Fibers are delivery devices that transmit laser energy from the laser console to the treatment site through the fiber tip. The laser connector secures the device to the laser.
Reason
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Identifiers
| code_info | Lot Code: All lot numbers for the following products: TFL-FBX150BS UDI: 00821925043923; TFL-FBX200BS UDI…Lot Code: All lot numbers for the following products: TFL-FBX150BS UDI: 00821925043923; TFL-FBX200BS UDI: 00821925043985; TFL-FBX150S UDI: 00821925043886; TFL-FBX200S UDI: 00821925043947; TFL-FBX365S UDI: 00821925044005; TFL-FBX550S UDI: 00821925044043; TFL-FBX940S UDI: 00821925044081; TFL-FBX150BS-JA (Japan Only); TFL-FBX550S-JA (Japan Only); TFL-FBX940S-JA (Japan Only); TFL-FBX200BS-JA (Japan Only); TFL-FBX150S-JA (Japan Only); TFL-FBX200S-JA (Japan Only); TFL-FBX365S-JA (Japan Only); |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1922-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.