Recall events
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Event 95831
Event summary
Timeline bucket August 23, 2024
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording WINGDERM ELECTRO-OPTICS LTD.
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Complete imported group
Every recalled product in this event
2 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 2
Non-ablative Fractional Laser Systems, Model: WFB-01
Z-0555-2025
Recall number Z-0555-2025
Initiated August 23, 2024
Classification Class II
Status Ongoing
Quantity Unavailable
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
software bug
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Radiation Control for Health and Safety Act
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0555-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[28705]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
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)
Code information F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001
Distribution pattern Worldwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[3624]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 2
Diode Laser Hair Removal model: WLA-01
Z-0556-2025
Recall number Z-0556-2025
Initiated August 23, 2024
Classification Class II
Status Ongoing
Quantity Unavailable
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
All model WLA-01 systems sold to US customers are found to have labeling non-compliances
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Radiation Control for Health and Safety Act
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0556-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[28713]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall All model WLA-01 systems sold to US customers are found to have labeling non-compliances
Code information F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001
Distribution pattern Worldwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[3904]
FDA event record
· Exact recall-number query on openFDA
