Which models and lots does a device recall cover?
A recall is matched to its jurisdiction, named product, catalog numbers and lots; a scoped accessory event does not describe every console.
The selected XERF EFFECTOR60 event illustrates the difference between a platform name and an affected accessory. The recorded status belongs to its observation date and is not a real-time safety certificate.
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What identifies the XERF recall event?
The event names EFFECTOR60 tips and specifies catalog numbers, lots and a manufacturing range.
The same manufacturer or platform name can appear on items outside a listed event. The source record must therefore stay attached to the named accessory and identifiers. The initial catalog preserves this as a selected US recall event rather than a complete safety history.
| Field | Recorded value |
|---|---|
| Jurisdiction | US |
| Accessory | EFFECTOR 60 |
| Catalog numbers | 1101210000, 1101210100, 1101210200 |
| Manufacturing range | 2025-04-01 to 2025-08-20 |
| Status observed | Open, Classified |
Why does a recall need the actual lot label?
The event’s listed lots distinguish the affected items from a broad product-family name.
When the lot is unknown, the claim checker returns a request to match the listed accessory and lot. It does not conclude that every unit is affected or that the unlabelled item is unaffected. A missing identity field remains unresolved.
| Listed lot | How to interpret it |
|---|---|
| MP60J25C02 | Retain the matching accessory, catalog number and jurisdiction |
| MP60J25G05 | Retain the matching accessory, catalog number and jurisdiction |
| MP60J25G06 | Retain the matching accessory, catalog number and jurisdiction |
| MP60J25H03 | Retain the matching accessory, catalog number and jurisdiction |
| MP60J25H01 | Retain the matching accessory, catalog number and jurisdiction |
Which dates belong to a recall record?
Manufacturing, firm action, posting and the research observation date are different fields.
A manufacturing range identifies the items described by the record. A posting date tells when the database published the entry. The observed status can change later. These dates do not supply a rate of injury or prove that the catalog has captured every later action.
Does the XERF event cover every console and tip?
The selected event is scoped to the listed EFFECTOR60 items and is not expanded to the whole platform.
The original event remains the authority for its named scope and action. A shortened headline can omit the lot or accessory qualification, so a consumer needs the actual record before attaching the event to an item. The catalog does not determine eligibility for a return or replace the manufacturer’s current instructions.
How does a clearance differ from a recall?
The clearance and recall are separate events with different purposes and identifiers.
The selected XERF clearance describes the device submission and its US indication. The EFFECTOR60 event concerns specified accessory items. A clearance does not mean a future safety event is impossible, while a scoped recall does not rewrite every earlier technical statement as a whole-platform finding.
Can recall listings rank complication risk?
A selected listing lacks the exposure denominator needed to calculate comparative complication rates.
The record’s existence is a fact about a reported event and action. It does not count every use of the device or all injuries under comparable conditions. A device with no entry in this catalog is not assigned a zero-risk score, because the research did not perform an exhaustive global surveillance review.
What should stay visible when a recall source changes?
Keep the prior observation, current source link and changed identifiers or status as dated records.
A later update can change status or the described scope. The source comparison should show the relationship rather than silently deleting the earlier observation. Model and lot matching remain necessary after an update, and current actions are read from the source rather than predicted by the catalog.
What else do people ask about Device recall lot scope?
What if the XERF lot is unknown?
The result remains lot matching required; it does not decide affected or unaffected status.
Is this a recall of every XERF console?
The selected event concerns the listed EFFECTOR60 accessories.
Is the displayed status real time?
It is a dated observation; the original source is linked for current reading.
Does no listed event mean no risk?
The catalog is not a complete surveillance history and assigns no zero-risk status.
Does the tool determine a return entitlement?
It matches document conditions, without replacing the manufacturer’s current action instructions.
Where do these numbers come from?
- Class 2 Device Recall XERF EFFECTOR 60 Research access: 2026-10-24. Recall Z-0146-2026, affected catalog numbers/lots, firm-initiated 2025-09-04, posted 2025-10-14, displayed Open/Classified, manufacturing-defect reason and stop-use/return action. Applies to listed tips, not every XERF device.
- K251327 : Xerf Research access: 2026-10-24. Decision letter identity/date; indications-for-use enclosure and/or summary; device-description/technology sections. Selected sections only, not a full IFU or full dossier.
- XERF - Structural Skin Tightening - Cynosure Lutronic Manufacturer first-party identity/technical source, not independent clinical evidence. Research access: 2026-10-24. Multifrequency monopolar RF, 2 and 6.78 MHz, cooling; US intended-use footer. No-numbing/no-downtime guarantees not adopted.