FDA recall Z-3188-2026

Boston Scientific Corporation · Class II · device

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 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.

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, MN, LA, WV, NV, PA, NH, NJ, MI, MO, AK, VA, MS, WY, ME 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.

Key facts

Status
Ongoing
Initiation date
2026-07-22
Report date
2026-09-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3188-2026