Olympus recalls SOLTIVE SuperPulsed Laser Fibers with model numbers TFL-FBX150S through TFL-FBX940S due to potential fiber breakage during use, which may cause burns, surgery delays, or foreign bodies in patients.
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.
Olympus is recalling SOLTIVE SuperPulsed Laser Fibers with specific model numbers because inconsistent cleaning instructions could cause the fiber to break during use. This poses risks like burns, surgery delays, or foreign objects in patients.
The fibers may break during use if cleaning instructions are followed incorrectly, leading to potential burns, surgery delays, or foreign objects entering the patient's body.
Healthcare professionals using these laser fibers for medical procedures are most at risk, particularly those who follow the current cleaning instructions without verifying the fiber's condition.
Check for model numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, or TFL-FBX150BS, TFL-FBX200BS. All lots produced under the listed UDI/GTIN numbers are affected.
Inspect the fiber for signs of breakage before use, as damaged fibers can cause burns or foreign bodies.
Ensure you follow the updated cleaning procedures to prevent fiber breakage during medical procedures.
Olympus identified inconsistencies in the cleaning instructions that could cause the fiber to break during use, leading to potential burns, surgery delays, or foreign objects in patients.
Model numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, and TFL-FBX200BS are affected.
No, but you should check for fiber breakage and follow updated cleaning instructions to prevent risks during procedures.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0748-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0748-2024 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
