Filing Flows › Boston Scientific (BSX) › Recalls, complaints & regulation
Boston Scientific (BSX): recalls, EPA violations, clinical trials and Federal Register
Boston Scientific (BSX) beyond its filings: 95 recalls in the last 12 months (409 in five years, 117 Class I); 1 EPA-regulated facility in violation, $11K in penalties over five years; 1 Federal Register document in a year; 71 active clinical trials.
Latest recalls
- 2026-10-28 · FDA device · Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290
- 2026-10-28 · FDA device · Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130; Material Number: M001195440
- 2026-10-28 · FDA device · Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M001195750
- 2026-10-28 · FDA device · Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155; Material Number: M001195280
- 2026-10-28 · FDA device · Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105; Material Number: M001195260
- 2026-10-28 · FDA device · Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130; Material Number: M001195840
- 2026-10-28 · FDA device · Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130; Material Number: M001195240
- 2026-10-28 · FDA device · Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/130; Material Number: M001195340
EPA facilities in violation
| Facility (as registered) | City | Status | Penalties |
|---|---|---|---|
| BOSTON SCIENTIFIC CORP. | Coventry, RI | Violation Identified | — |
Facilities in the EPA's ECHO register whose registered name matches the company's; a facility can belong to another business of the same name.
Boston Scientific's latest quarter
Boston Scientific, Q3 2026: revenue $5.1B (+1% year over year), operating margin 16.1%, net earnings $580M, operating cash flow $1.0B. The chart follows the revenue to costs, profit and cash.
Questions
Has Boston Scientific had any recalls?
409 recalls on file over five years from the FDA, CPSC and NHTSA; 95 in the last 12 months.
Has Boston Scientific been fined by the EPA?
The 60 EPA-regulated facilities on file under its name drew $11K in penalties over five years; 1 is in violation now.
How many clinical trials does Boston Scientific have?
71 active studies on ClinicalTrials.gov, 2 in phase 3.
Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.