SOLTIVE recallZ-0718-2024 · Olympus Corporation of the Americas · initiated Dec 4, 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
Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient).
FDA root cause category: Under Investigation by firm
What the company is doing
On December 4, 2023, the firm notified affected customers via Urgent Medical Device Removal letters. Customers were instructed to identify and quarantine the affected model/lot. Affected product should not be used. Olympus will issue a credit to customers upon the return of the affected product. If product was distributed outside the customer's facility, the customer should notify those outside facilities immediately. If you require additional information, please contact the company by phone at (647) 999-3203 or by e-mail at [email protected].
Recall details
- Recall number
- Z-0718-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 4, 2023
- Posted by the FDA
- Jan 12, 2024
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 179 units
- Product code
- GEX
- FDA submissions
- K221306
- Distribution
- Domestic distribution to the following states: AK AR AZ CA FL GA IA ID IN KS KY LA MA MI NC ND NE NJ NY OR PA SC SD TN TX VA WI International distribution to Canada, Latin America, and Europe.
Product description
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Code information (models, lots, serial numbers)
UDI-DI 00821925043985 Lot KR262848
Devices named in this recall
1 device 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
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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