Recall Z-3188-2026— Boston Scientific Corporation

Name: FDA recall Z-3188-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-22

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2026-07-22. It names one FDA 510(k) clearance: K233645. Product: Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort Cable REF: M0067933000, M006793300H0, M006793300R0, M006793300D0, M006793300Z0, M0067930000, M006793000R0. Reason: A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-07-22
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K233645 — StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse DeflectionBoston Scientific Corporation -·cleared 2023-12-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort Cable REF: M0067933000, M006793300H0, M006793300R0, M006793300D0, M006793300Z0, M0067930000, M006793000R0

Reason for recall

A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation.

Data sourced from openFDA. This site is unofficial and independent of the FDA.