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Use caution Medical device recall · FDA · Published July 22, 2026

Boston Scientific StoneSmart Connect Console Power Adapters May Fail Safety Testing

Boston Scientific recalls StoneSmart Connect Console power adapters with higher-than-expected grounding resistance that may fail electrical safety tests during installation. Affected units include specific model numbers and serial ranges.

🇺🇸 FDA recall #Z-3188-2026Medical deviceBoston Scientific ›
✎ GovInfoNow plain-language explainer

Boston Scientific is recalling power adapters for their StoneSmart Connect Console due to potential electrical safety issues. These adapters may fail safety testing during installation, which could lead to electrical hazards if used improperly. Read more at govinfonow.com/recall/1134704-boston-scientific-stonesmart-connect-console-power-adapters-may-fail-safety.

Source Summary by GovInfoNow · govinfonow.com/recall/1134704-boston-scientific-stonesmart-connect-console-power-adapters-may-fail-safety · Updated October 4, 2026 · FDA enforcement record: FDA #Z-3188-2026

Cite this page

“Boston Scientific StoneSmart Connect Console Power Adapters May Fail Safety Testing.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/1134704-boston-scientific-stonesmart-connect-console-power-adapters-may-fail-safety. Based on FDA recall #Z-3188-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3188-2026%22&limit=1).

The FDA announced on July 22, 2026, that Boston Scientific Corporation is recalling StoneSmart Connect Consoles due to power adapter safety concerns. The agency said the recall affects units distributed worldwide.

How to tell if you have it

  • Brand: Boston Scientific
  • Product: StoneSmart Connect Console
  • REF codes: M0067933000, M006793300H0, M006793300R0, M006793300D0, M006793300Z0, M0067930000, M006793000R0
  • UPN: M0067933100
  • Units affected: 982

The hazard

According to the FDA, 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.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Recent recalls include the Aug. 24, 2026, Imager II Angiographic Catheters Recall for tip fracture risk and the Aug. 6, 2026, LUX-Dx Cardiac Monitor System Recall for delayed AF burden alerts. Other recent recalls of similar products include the April 29, 2026, CSK Electrodes Recall and the April 29, 2026, TCN Electrodes Recall for performance level issues.

How to tell if you have this one

Check for the model numbers M0067933000, M006793300H0, M006793300R0, M006793300D0, or M006793300Z0 on the adapter. The recall includes specific serial numbers and unique identifiers (UDIs) listed in the record.

  • Brand
    Boston Scientific
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Adapter Model

    Identify the model number on the power adapter to see if it matches the recalled models listed in the recall notice.

  2. Contact Boston Scientific

    Reach out to Boston Scientific for guidance on whether your adapter is affected and what steps to take next.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 44 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution including in the states of AZ, FL, CA, OR, IL, NC, NE, UT, CO, OH, AR, NM, AL, WI, TN, IN, GA, OH, WI, KY, CT, KS, SC, IL, NE, MO, MS, DE, TX, NY, WV, MA, MT, WA, WY, NV, HI, ID, MO, ME, WV, NE, OK,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Jul 22, 202612. FDA classified it Class II: Sep 16, 202623. Published in FDA’s Enforcement Report: Sep 23, 202634. Added to GovInfoNow: Sep 29, 202642026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Do I need to stop using the adapter immediately?

The recall does not require immediate discontinuation; contact Boston Scientific to determine if your adapter is affected.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-3188-2026 (July 22, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3188-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA