CLASS II ONGOING Device recall · Reported 30 Oct 2024 · FDA Enforcement Report
Soltive Premium SuperPulsed Laser - Intended for incision recalled
Olympus Corporation of the Americas is recalling Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, distributed nationwide in the US. The recall was initiated on 13 Aug 2024 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-0134-2025
- FDA event ID
- 95380
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Aug 2024
- FDA classified
- 18 Oct 2024
- Reported
- 30 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 13 Aug 2024 | Recall initiated by company | |
| 18 Oct 2024 | Classified by FDA | +66 days |
| 30 Oct 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.
Product as listed by the FDA
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS
Where it was distributed
Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
Questions about this recall
Why was it recalled?
The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.
Which lots are affected?
UDI 00821925044111 All Serial Numbers:
Where was it sold?
Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
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.
Other products in this recall event
1 other product · FDA event 95380| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Soltive Pro SuperPulsed Laser Systems-Intended for incision recalled | Olympus Corporation of the Americas | Other | Nationwide |
More recalls from Olympus Corporation of the Americas
All 415| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Powerseal (in diameter) (long), Curved Jaw Sealer & Divider recalled | Olympus Corporation of the Americas | Labeling Errors | Nationwide |
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