RecallReported September 23, 2026
Class II recall by Boston Scientific Corporation
Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (…
FDA's enforcement report of September 23, 2026 lists a Class II recall by Boston Scientific Corporation of Marlborough, MA. Product: Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (…. Status: Ongoing.
On the record
- Recalling firm
- Boston Scientific Corporation
- Location
- Marlborough, MA
- Classification
- Class II
- Status
- Ongoing
- Recall number
- Z-3188-2026
- Product type
- Devices
- Recall initiated
- 2026-07-22
- Reported by FDA
- 2026-09-23
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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