Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

RSS Feed

Home
/
Brands
/
Boston Scientific Corporation

Boston Scientific Corporation Recalls

All product recalls associated with Boston Scientific Corporation.

Get alerts for this brand

Recall Summary

Total Recalls

1000

Past Year

567

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 281–300 of 7756 recalls

UroMax Ultra Kit (Boston Scientific) – technical issue (2025)

The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.

FDAAug 5, 2025Nationwide• Boston Scientific Corporation

Encore Advantage Kit (Boston Scientific) – technical issue (2025)

FDAAug 5, 2025Nationwide• Boston Scientific Corporation

NephroMax Kit (Boston Scientific) – technical issue (2025)

1...13 141516 17...388

Page 15 of 388Next

FDAAug 5, 2025Nationwide• Boston Scientific Corporation

Encore 26 Inflation Device (Boston Scientific) – technical issue (2025)

FDAAug 5, 2025Nationwide• Boston Scientific Corporation

DxC 500 Analyzer (Beckman Coulter) – test processing issue (2025)

On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.

FDAAug 4, 2025Nationwide• Beckman Coulter Inc.

Novum IQ Syringe Pump (Baxter) – device correction (2025)

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).

FDAAug 4, 2025PR• Baxter Healthcare Corporation

Novum IQ Large Volume Pump (Baxter) – device correction (2025)

FDAAug 4, 2025PR• Baxter Healthcare Corporation

Fortress Introducer Sheath (Contract Medical) – labeling error (2025)

Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.

FDAJul 30, 2025Nationwide• Contract Medical International GmbH Lauensteiner Str. 37 Dresden Germany

WATCHMAN TruSteer Access System (Boston Scientific) – air embolism (2025)

Laceration Risk

Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.

FDAJul 29, 2025Nationwide• Boston Scientific Corporation

Ortoma Inserter Adapter (Ortoma) – weld breakage (2025)

Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.

FDAJul 28, 2025Nationwide• ORTOMA AB Falkenbergsgatan 3 Goteborg Sweden

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Class IIModerate

FDAJul 25, 2025AZ, IN, NJ• Breckenridge Pharmaceutical, Inc.

Doxepin Hydrochloride Capsules (Alembic) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Class IIModerate

FDAJul 25, 2025Nationwide• Alembic Pharmaceuticals Limited

Endotak Reliance Lead (Boston Scientific) – Measurement Inconsistency (2025)

Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.

FDAJul 24, 2025Nationwide• Boston Scientific Corporation