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U.S. Department of Health and Human Services

Class 2 Device Recall StoneSmart Connect Console

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 Class 2 Device Recall StoneSmart Connect Consolesee related information
Date Initiated by FirmJuly 22, 2026
Date PostedSeptember 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3188-2026
Recall Event ID 99630
510(K)NumberK233645 
Product Classification Ureteroscope and accessories, flexible/rigid - Product Code FGB
ProductBoston 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
Code Information 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)
FEI Number 3005099803
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information ContactClara Johnson
763-494-1133
Manufacturer 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 Determined
Cause 2		Nonconforming Material/Component
ActionOn 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 Commerce982 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FGB
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