Olympus Soltive Laser System Recall: Wireless Footswitch Pairing Issues

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Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Olympus is recalling its Soltive Premium SuperPulsed Laser System (Model TFL-PLS) because wireless footswitch pairing issues could delay surgical procedures. This affects all units sold with the model number TFL-PLS.

Why it’s dangerous

The wireless footswitch may not pair correctly with the laser system, causing delays in surgery. This could lead to extended procedure times or other complications during medical procedures.

Who’s affected

Surgical staff using the Soltive Premium SuperPulsed Laser System Model TFL-PLS are most affected. Patients and medical teams using this device may experience procedural delays.

How to tell if you have this one

Check for the model number TFL-PLS on the device. All units with this model number are affected, regardless of serial number.

Brand
Olympus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Look for the model number TFL-PLS on the device to confirm it is affected.

✎ GovInfoNow

Questions people ask

Is there a fix for the wireless footswitch pairing issue?

The recall record does not mention a fix or remedy for the pairing issue.

How can I tell if my device is affected?

Check for the model number TFL-PLS on the device. All units with this model number are affected.

Do I need to stop using the device immediately?

The recall does not require immediate stop use; the hazard is low risk and only affects pairing.

Take action

Contact Olympus

We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2504-2024 — Olympus Olympus

Hello,

I own a Olympus that is covered by recall Z-2504-2024 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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Where this comes from

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.

Official source: FDA Recall #Z-2504-2024 (May 31, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2504-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Olympus Corporation of the Americas recalls Soltive Premium SuperPulsed Laser System, Model TFL-PLS

Lower-risk recall