Reported Aug 14, 2024 · Ongoing
Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL
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?
- Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL
- Lot codes and dates
- ModelTFL-AFSWL
- UDI-DI00821925044258
- Serial NumbersAll Serial Numbers
- Amount recalled
- 1,838 Units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
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.
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