Recall Z-1296-2022 · GEX Powered Laser Surgical Instrument
Olympus Corporation of the Americas
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 # Label
| Date | May 26, 2022 |
| Status | Terminated |
| 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. |
| Root cause | Labeling mix-ups |
| Action | Firm notified customers by letter on May 26, 2022. Customers were instructed to return on hand inventory to Olympus for credit. |
| Quantity | 190 cartons (950 pieces total) |
| Distribution | Nationwide distribution in the US. Foreign distribution worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183647 | SOLTIVE Laser System(SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVELaser Fibers, and Acce Olympus Surgical Technologies America, Aug 9, 2019 |