Z-3188-2026Class II

Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI...

Name: Z-3188-2026 Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI...
Creator: Boston Scientific Corporation
Published: 2026-07-22
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2026-07-22 / Open, Classified

FDA source

Recall record

Recall number: Z-3188-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-22
Posted: 2026-09-16
Recalling firm: Boston Scientific Corporation
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
Product code: FGB Ureteroscope And Accessories, Flexible/Rigid
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.
FDA root cause: Nonconforming Material/Component
Action: On July 22, 2026, Boston Scientific Corporation issued a medical device correction to affected consignees via FedEx letter, Boston Scientific Corporation requested consignees to take the following actions: 1. Continue to use the affected devices according to the Instructions for Use. 2. Forward this notice to relevant personnel and any facilities to which the impacted device was transferred. 3. Complete and return the enclosed Acknowledgement Form. 4. Begin using the replacement power adaptor upon receipt and dispose of the affected power adaptor in accordance with local requirements.
Quantity in commerce: 982 units
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.
Product codes and lots: All Serial Numbers: REF: M0067933000 (UDI 00191506002510, UDI (00191506021771); REF: M006793300H0 (UDI 00191506002558); REF: M006793300R0 (UDI 00191506002534), UDI (00191506021788); REF: M006793300D0 (UDI 00191506002527); REF: M006793300Z0 (UDI 00191506002541); UPN M0067933100 (UDI 00191506022549)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3188-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3188-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16

Product code FGB

K233645Class IIStoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse DeflectionBoston Scientific Corporation - / cleared 2023-12-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-23. View this recall on fda.gov (opens on fda.gov)