Boston Scientific Corporation recalls Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort Cable7 codes
- M0067933000
- M006793300H0
- M006793300R0
- M006793300D0
- M006793300Z0
- M0067930000
- M006793000R0
Lot / code information
- 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)
Show 3 more code fieldsShow fewer
What the firm is doing
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.
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3188-2026
- FDA 510(k) clearance · K233645The device's official FDA premarket clearance record
- FDA device classification · FGBOfficial FDA classification for this device type
- CFR regulation · 21 CFR 876.1500The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Boston Scientific CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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