FDA Device recall Z-1296-2022
SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX200S (…
- FDA Device
- Class II
- terminated
- Published 2022-07-06
On 2022-07-06 the FDA classified a Class II recall of SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX200S (… by Olympus, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1296-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-05-26 |
| Published | 2022-07-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Olympus |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI-DI Lot Model# Labeled 00821925043923 KR149856 TFL-FBX150BS (Carton) 00821…UDI-DI Lot Model# Labeled 00821925043923 KR149856 TFL-FBX150BS (Carton) 00821925043923 KR149856 TFL-FBX200S (Pouch) 00821925043985 KR195775 TFL-FBX200BS (Carton) 00821925044043 KR197789 TFL-FBX550S (Carton) 00821925043930 KR206254 TFL-FBX200S (Carton) 00821925043930 KR206254 TFL-FBX365S (Pouch) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1296-2022%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.