Reported Jun 18, 2025 · Ongoing
Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number:…
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 Reusable
- Laser Fibers Model/Catalog Number
TFL-FBX150RTFL-FBX200RTFL-FBX365RTFL-FBX550RTFL-FBX940RTFL-FBX940R-JA (Japan Only)TFL-FBX365R-JA (Japan Only)TFL-FBX200BS-JA (Japan Only)TFL-FBX150R-JA (Japan Only)TFL-FBX200R-JA (Japan Only)TFL-FBX550R-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
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 00821925043893008219250439090082192504395400821925043961008219250440120082192504402900821925044050008219250440670082192504410400821925044098Lot Code: All lot numbers for the following models: Model UDI: 5 Pack / 1 Piece: TFL-FBX150R UDI: 00821925043893 / 00821925043909 TFL-FBX200R UDI: 00821925043954 / 00821925043961 TFL-FBX365R UDI: 00821925044012 / 00821925044029 TFL-FBX550R UDI: 00821925044050 / 00821925044067 TFL-FBX940R UDI: 00821925044104 / 00821925044098 TFL-FBX940R-JA (Japan Only) 2 TFL-FBX365R-JA (Japan Only) 3 TFL-FBX200BS-JA (Japan Only) 4 TFL-FBX150R-JA (Japan Only) 5 TFL-FBX200R-JA (Japan Only) 6 TFL-FBX550R-JA (Japan Only) - Amount recalled
- 2,675 units (190 US, 2485 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Olympus Corporation of the Americas recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.