Boston Scientific recalls
5 Boston Scientific recalls in our records, 2 of them in the most serious category. The latest: Boston Scientific recall: Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5 (Sep 30, 2026).
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| 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 23, 2026 | Boston Scientific recall: Corporation StoneSmart Connect Console Contents:Medical devices · 982 units | A subset of power adapters used with the connect console may exhibit higher-than-expected … Serious | FDA Class II |
| 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 |
Boston Scientific recall questions
Is there a Boston Scientific recall right now?
The most recent Boston Scientific recall in our records: Boston Scientific recall: Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5, published by FDA on September 30, 2026.
How many Boston Scientific recalls have there been?
5 since August 26, 2026 in our records (5 medical devices), 2 of them in the most serious category.
How do I check if my Boston Scientific product is included?
Open the recall and compare the lot codes, UPCs, dates or model numbers with what you have; only the items listed are recalled.
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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.