CLASS II ONGOING Device recall · Reported 11 Dec 2024 · FDA Enforcement Report
Non-ablative Fractional Laser Systems recalled
Wingderm Electro-optics is recalling Non-ablative Fractional Laser Systems. The recall was initiated on 23 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-0555-2025
- FDA event ID
- 95831
- Recalling firm
- Wingderm Electro-optics, Beijing
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Aug 2024
- FDA classified
- 5 Dec 2024
- Reported
- 11 Dec 2024
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 23 Aug 2024 | Recall initiated by company | |
| 5 Dec 2024 | Classified by FDA | +104 days |
| 11 Dec 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units)
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Non-ablative Fractional Laser Systems, Model: WFB-01
Where it was distributed
Worldwide Distribution
Questions about this recall
Why was it recalled?
Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units)
Which lots are affected?
F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001
Where was it sold?
Worldwide 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 95831| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Diode Laser Hair Removal recalled by Wingderm Electro-optics | Wingderm Electro-optics | Other |
More recalls from Wingderm Electro-optics
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Diode Laser Hair Removal recalled by Wingderm Electro-optics | Wingderm Electro-optics | Other |
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| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |