Olympus Soltive Laser System Recall: Wireless Footswitch Pairing Issues
Olymp: Soltive Premium SuperPulsed Laser System Model TFL-PLS has wireless footswitch pairing difficulties that may delay surgery. Affected units include all serial numbers.
Lower-risk recall
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Contact the company
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. Read more at govinfonow.com/recall/54959-olympus-soltive-laser-system-recall-wireless-footswitch-pairing-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/54959-olympus-soltive-laser-system-recall-wireless-footswitch-pairing-issues · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2504-2024
Cite this page
“Olympus Soltive Laser System Recall: Wireless Footswitch Pairing Issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54959-olympus-soltive-laser-system-recall-wireless-footswitch-pairing-issues. Based on FDA recall #Z-2504-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2504-2024%22&limit=1).
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
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2504-2024 | Soltive Premium SuperPulsed Laser System, Model TFL-PLS; Model: TFL-PLS; UDI-DI: 00821925044111; Serial Numbers: All Serial Numbers. | 1,585 Units |
| Z-2505-2024 | Soltive Pro SuperPulsed Laser System, Model TFL-SLS; Model: TFL-SLS; UDI-DI: 00821925044135; Serial Numbers: All Serial Numbers. | 253 Units |
| Z-2506-2024 | Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL; Model: TFL-AFSWL; UDI-DI: 00821925044258; Serial Numbers: All Serial Numbers. | 1,838 Units |
What to do — step by step
Check Device Model
Look for the model number TFL-PLS on the device to confirm it is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
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.
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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.