CLASS II Device recall · Reported 25 Aug 2021 · FDA Enforcement Report
Soltive Premium Super Pulsed Laser System recalled
Olympus Corporation of the Americas is recalling Soltive Premium Super Pulsed Laser System (Tfl-pls) & Pro Super Pulsed Laser System, distributed nationwide in the US. The recall was initiated on 30 Jun 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2294-2021
- FDA event ID
- 88229
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jun 2021
- FDA classified
- 15 Aug 2021
- Reported
- 25 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 30 Jun 2021 | Recall initiated by company | |
| 15 Aug 2021 | Classified by FDA | +46 days |
| 25 Aug 2021 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets
Product as listed by the FDA
Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological surgery
Where it was distributed
US Nationwide Distribution Foreign: Canada Australia Japan Hong Kong Europe Singapore
Questions about this recall
Why was it recalled?
Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets
Which lots are affected?
Software Version 2.0 (all serial numbers)
Where was it sold?
US Nationwide Distribution Foreign: Canada Australia Japan Hong Kong Europe Singapore
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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