SOLTIVE recallZ-1296-2022 · Olympus Corporation of the Americas · initiated May 26, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling mix-ups
What the company is doing
Firm notified customers by letter on May 26, 2022. Customers were instructed to return on hand inventory to Olympus for credit.
Recall details
- Recall number
- Z-1296-2022
- Status
- Terminated
- Initiated by the company
- May 26, 2022
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 190 cartons (950 pieces total)
- Product code
- GEX
- FDA submissions
- K183647
- Distribution
- Nationwide distribution in the US. Foreign distribution worldwide.
Product description
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
Code information (models, lots, serial numbers)
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)
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- SOLTIVE TFL-FBX200BSGyrus ACMI, LLC · Powered Laser Surgical Instrument4 recalls84 reports
- SOLTIVE TFL-FBX200SGyrus ACMI, LLC · Powered Laser Surgical Instrument3 recalls93 reports
- SOLTIVE TFL-FBX550SGyrus ACMI, LLC · Powered laser surgical instrument3 recalls63 reports
- SOLTIVE TFL-FBX150BSGyrus ACMI, LLC · Powered Laser Surgical Instrument3 recalls18 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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