Olympus recalls SOLTIVE SuperPulsed Laser Fibers Model TFL-FBX200BS due to potential breached sterile pouch seals that could cause procedure delays or patient infections if not noticed before use.
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).
Olympus is recalling SOLTIVE SuperPulsed Laser Fibers with model number TFL-FBX200BS because they may have a broken sterile pouch seal. This could lead to minor delays in medical procedures or infections if the seal isn't checked before use.
The sterile pouch seal might be broken, which could let bacteria enter the laser fibers. If the broken seal isn't noticed before use, it might cause minor delays in medical procedures or infections in patients.
Patients and medical professionals using the SOLTIVE SuperPulsed Laser Fibers with model number TFL-FBX200BS are affected. Those who have the product and check the sterile pouch seal before use are at lowest risk.
Check for the model number TFL-FBX200BS on the product. The product was sold with UDI-DI 00821925043985 and lot number KR262848.
Inspect the sterile pouch seal for any signs of damage or breaches before use.
The recall states the risk is minor procedure delays or patient infections if the seal isn't checked before use. Serious injury is not mentioned.
Look for the model number TFL-FBX200BS and UDI-DI 00821925043985 with lot number KR262848.
Check the sterile pouch seal for damage before use. If the seal is breached, contact Olympus for further instructions.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0718-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0718-2024 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.
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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.
