Boston Scientific StoneSmart Connect Console
The StoneSmart Connect Console has power adapters with higher-than-expected resistance in the electrical grounding path.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Boston Scientific Corporation, based in Marlborough, Massachusetts, voluntarily recalled its StoneSmart Connect Console on July 22, 2026. The recall was initiated because a subset of power adapters used with the console may exhibit higher-than-expected resistance in the electrical grounding path, which could cause the power adaptor to fail electrical safety testing during installation. The recall involves 982 units and was added to the FDA's Enforcement Report on September 16, 2026.
The affected consoles were distributed worldwide, including nationwide in the United States across states such as Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming.
International distribution included Australia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Lebanon, Norway, Poland, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Turkiye, Canada, Hong Kong, Singapore, Taiwan, Argentina, Chile, and Japan. Customers were notified by letter.
The FDA classified the recall on September 16, 2026, and it was in the weekly enforcement report on September 23, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Product details
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
- UDI-DI
- 00191506002510
- 00191506021771
- 00191506002558
- 00191506002534
- 00191506021788
- 00191506002527
- 00191506002541
- 00191506022549
- Lot
- All Serial Numbers: REF: M0067933000 (UDI 00191506002510, UDI (00191506021771)
Details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution including in the states of Arizona, Florida, California, Oregon, Illinois, North Carolina, Nebraska, Utah, Colorado, Ohio, Arkansas, New Mexico, Alabama, Wisconsin, Tennessee, Indiana, Georgia, Ohio, Wisconsin, Kentucky, Connecticut, Kansas, South Carolina, Illinois, Nebraska, Missouri, Mississippi, Delaware, Texas, New York, West Virginia, Massachusetts, Montana, Washington, Wyoming, Nevada, Hawaii, Idaho, Missouri, Maine, West Virginia, Nebraska, Oklahoma, Minnesota, Louisiana, West Virginia, Nevada, Pennsylvania, New Hampshire, New Jersey, Michigan, Missouri, Alaska, Virginia, Mississippi, Wyoming, Maine and the countries of Australia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Lebanon, Norway, Poland, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Turkiye, Canada, Hong Kong, Singapore, Taiwan, Argentina, Chile, Japan.
- Event ID
- 99630
- Recall No.
- Z-3188-2026
- Company
- Boston Scientific CorporationMarlborough, Massachusetts
- Hazard
- Device defect
- Quantity recalled
- 982 units
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
