CLASS II ONGOING Device recall · Reported 24 Jan 2024 · FDA Enforcement Report
Soltive SuperPulsed Laser System TFL Fiber Stripper recalled
Olympus Corporation of the Americas is recalling Soltive SuperPulsed Laser System TFL Fiber Stripper, distributed nationwide in the US. The recall was initiated on 4 Dec 2023 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-0716-2024
- FDA event ID
- 93613
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Dec 2023
- FDA classified
- 12 Jan 2024
- Reported
- 24 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Masks, Gloves & PPE
Timeline
| 4 Dec 2023 | Recall initiated by company | |
| 12 Jan 2024 | Classified by FDA | +39 days |
| 24 Jan 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 strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
Where it was distributed
US Nationwide. Global Distribution
Questions about this recall
Why was it recalled?
The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination.
Which lots are affected?
Lot Number: All units sold prior to 2023
Where was it sold?
US Nationwide. Global Distribution
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 93613| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Soltive SuperPulsed Laser System Tfl Fiber Cleaver recalled | Olympus Corporation of the Americas | Sterility | Nationwide |
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|---|---|---|---|---|---|
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