SOLTIVE recallZ-0748-2024 · Olympus Corporation of the Americas · initiated Dec 1, 2023
Open, Classified
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
Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to break during use, which may cause burns, procedure delays, prolonged surgery, and foreign body in patient.
FDA root cause category: Labeling Change Control
What the company is doing
On December 1, 2023, the firm issued URGENT MEDICAL DEVICE CORRECTION letters to affected customers. Customers were provided with copies of the labeling addendum to add to remaining inventory. Customers may continue to use the product, but this should be done in accordance with the labeling addendum. If you require additional information, please contact Olympus at (647) 999-3203 or at [email protected].
Recall details
- Recall number
- Z-0748-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 1, 2023
- Posted by the FDA
- Jan 18, 2024
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 82,200 total units (5 per box)
- Product code
- GEX
- FDA submissions
- K183647
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Europe, Hong Kong, Australia, Japan, Singapore, and Latin America.
Product description
SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS
Code information (models, lots, serial numbers)
Models UDI/GTIN TFL-FBX150S 00821925043916 TFL-FBX200S 00821925043930 TFL-FBX365S 00821925043992 TFL-FBX550S 00821925044036 TFL-FBX940S 00821925044074 TFL-FBX150BS 00821925043879 TFL-FBX200BS 00821925043978 All lots affected
Devices named in this recall
7 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
- SOLTIVE TFL-FBX150SGyrus ACMI, LLC · Powered Laser Surgical Instrument2 recalls21 reports
- SOLTIVE TFL-FBX365SGyrus ACMI, LLC · Powered Laser Surgical Instrument2 recalls11 reports
- SOLTIVE TFL-FBX940SGyrus ACMI, LLC · Powered Laser Surgical Instrument2 recalls1 report
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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