Boston Scientific recall: Corporation StoneSmart Connect Console Contents:
Boston Scientific Corporation is recalling Boston Scientific Corporation StoneSmart Connect Console Contents: – 982 units. The U.S. Food and Drug Administration published the recall on September 23, 2026; it began on July 22, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Boston Scientific Corporation StoneSmart Connect Console Contents: |
| Brand | Boston Scientific |
| Company | Boston Scientific Corporation |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 22, 2026 |
| Published by FDA | September 23, 2026 |
| Quantity | 982 units |
| Recall ID | 99630 |
Recalled products
- 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
- FDA recall number
- Z-3188-2026
- Codes, lots and dates
- 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)
- Quantity
- 982 units
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99630
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Marlborough, MA, United States
Why it was recalled
The reason the FDA lists: “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.”
Where it was sold
Nationwide. Distribution as the FDA records it: “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.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99630, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other Boston Scientific recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Sep 30, 2026 |  Boston Scientific recall: Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5Medical devices · 262,686 | Tip may fracture or detach, leading to device fragments remaining within the patient or mi… Most serious | FDA Class I |
| Sep 9, 2026 | Boston Scientific recall: LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS…Medical devices · N/A | There is potential for a delay in AF Burden Alert notification affecting the server softwa… Serious | FDA Class II |
| Aug 26, 2026 | Boston Scientific recall: ENROUTE Transcarotid Neuroprotection System and 1 more productMedical devices · 115,458 units; 49,229 units | Potential for arterial sheath tip separation or partial tip separation during use. Most serious | FDA Class I |
| Aug 26, 2026 | Boston Scientific recall: OverStitch Suture Cinch and 1 more productMedical devices · 60,654 units | Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. Serious | FDA Class II |
All 5 Boston Scientific recalls →
About this recall
Is Boston Scientific Boston Scientific Corporation StoneSmart Connect Console Contents: recalled?
Yes. Boston Scientific Corporation recalled it on July 22, 2026; FDA published it September 23, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
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.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.