RecallReported September 9, 2026
Class II recall by Boston Scientific Corporation
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)
FDA's enforcement report of September 9, 2026 lists a Class II recall by Boston Scientific Corporation of Saint Paul, MN. Product: LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7). Status: Ongoing.
On the record
- Recalling firm
- Boston Scientific Corporation
- Location
- Saint Paul, MN
- Classification
- Class II
- Status
- Ongoing
- Recall number
- Z-3083-2026
- Product type
- Devices
- Recall initiated
- 2026-08-06
- Reported by FDA
- 2026-09-09
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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