Reported Jun 18, 2025 · Ongoing
Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog…
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- Brand NamePowered
- Laser Surgical Instrument Product NameSoltive SuperPulsed Laser Fibers -
- Single Use Model/Catalog Numbers
TFL-FBX150BSTFL-FBX200BSTFL-FBX150STFL-FBX200STFL-FBX365STFL-FBX550STLF-FBX940STFL-FBX150BS-JA (Japan Only)TFL-FBX550S-JA (Japan Only)TFL-FBX940S-JA (Japan Only)TFL-FBX200BS-JA (Japan Only)TFL-FBX150S-JA (Japan Only)TFL-FBX200S-JA (Japan Only)TFL-FBX365S-JA (Japan Only)
- Product DescriptionSOLTIVE Laser Fibers are delivery devices that transmit laser energy from the laser console to the treatment site through the fiber tip. The laser connector secures the device to the laser
- Lot codes and dates
14 of 14 products
Products covered by this recall # Barcodes Product as published 1 00821925043923Lot Code: All lot numbers for the following products: TFL-FBX150BS UDI: 00821925043923 2 00821925043985TFL-FBX200BS UDI: 00821925043985 3 00821925043886TFL-FBX150S UDI: 00821925043886 4 00821925043947TFL-FBX200S UDI: 00821925043947 5 00821925044005TFL-FBX365S UDI: 00821925044005 6 00821925044043TFL-FBX550S UDI: 00821925044043 7 00821925044081TFL-FBX940S UDI: 00821925044081 8 TFL-FBX150BS-JA (Japan Only) 9 TFL-FBX550S-JA (Japan Only) 10 TFL-FBX940S-JA (Japan Only) 11 TFL-FBX200BS-JA (Japan Only) 12 TFL-FBX150S-JA (Japan Only) 13 TFL-FBX200S-JA (Japan Only) 14 TFL-FBX365S-JA (Japan Only) - Amount recalled
- 551,154 units (417859 US, 133710 OUS)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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