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
FDA Recall Z-1296-2022 · Posted None
Recalling FirmOlympus Corporation of the Americas
Recall StatusTerminated
Product CodeGEX
Date Initiated2022-05-26
Date Terminated2025-02-05
Product Quantity190 cartons (950 pieces total)
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.
Firm Action
Firm notified customers by letter on May 26, 2022. Customers were instructed to return on hand inventory to Olympus for credit.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide distribution in the US. Foreign distribution worldwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.