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Boston Scientific Corporation

Boston Scientific Corporation Recalls

All product recalls associated with Boston Scientific Corporation.

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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 2921–2940 of 7756 recalls

Boston Scientific Corporation: IceFORCE" 2.1 CX Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

FDANov 18, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: IceFORCE" 2.1 CX 90 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

FDANov 18, 2020Nationwide• Boston Scientific Corporation

Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom: Tempus LS - Manual Defibrillator, Model Number: 00-3020 S...

A software error was detected within software version 1.3.4 for the Tempus LS device. When exiting pacer back into manual mode the pacer pulse wave may put the ECG calibration out of calibration. This software error may result in a delay in therapy, as the clinician is not provided an ECG waveform on which a shockable rhythm decision can be made. The device is still able to deliver a manual defibrillation shock.

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FDANov 17, 2020Nationwide• Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom

Boston Scientific Corporation: Lotus Edge Valve System, Transcatheter Aortic Valve Prost...

Laceration Risk

Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.

FDANov 17, 2020AL, AZ, AR +35 more• Boston Scientific Corporation

Kollidon CL-M Crospovidone (BASF) – Cross Contamination (2020)

Cross contamination: the excipient was found to be contaminated with theophylline.

Class IIModerate

FDANov 17, 2020Nationwide• BASF Corporation

Boston Scientific Corporation: Contour VL Variable Length Ureteral Stent, UPN M006180155...

Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.

FDANov 16, 2020Nationwide• Boston Scientific Corporation

Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland: Randox Mg R1 - Product Usage: For the quantitative in vit...

Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine

FDANov 13, 2020Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Boston Scientific Corporation: EMBLEM S-ICD Subcutaneous Electrode Model 3501. Componen...

There is potential for fractures which results in the inability to delivery therapy.

FDANov 13, 2020Nationwide• Boston Scientific Corporation

Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland: Randox Rx Series Mg - Product Usage: For the quantitative...

Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine

FDANov 13, 2020Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Electric Throw Heated Blankets (InvoSpa) – fire burn hazard (2020)

Fire/Burn Risk

This recall involves InvoSpa electric throw heated blankets. The recalled blankets measure 50 inches by 60 inches. The blankets are made of silky flannel and sherpa shu velveteen and are white and gray. Model number ML-G03 and InvoSpa are printed on a tag on the blanket.

CPSCNov 12, 2020Nationwide• Hebei Yuwang Electrical Appliance Co. Ltd, of China

Biocomposites, Ltd. Keele Science Park Keele Staffordshire United Kingdom: Stimulan Kit 10cc, Model 600-010 - Product Usage: intende...

The product is mislabeled.

FDANov 12, 2020Nationwide• Biocomposites, Ltd. Keele Science Park Keele Staffordshire United Kingdom

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, Ray...

Two issues were found with the treatment plan report: 1) There may be incorrect information for the percent of a region of interest with a clinical goal that is outside the dose grid; and 2) For RayStation and RayPlan 9B and 10A, 6D couch angles may be incorrect.

FDANov 11, 2020Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

Baxter Healthcare Corporation: MiniCap Extended Life PD Transfer Set

Potential for no-flow and leaks under the twist clamp.

FDANov 10, 2020Nationwide• Baxter Healthcare Corporation

Wintergreen Essential Oil (Crafty Bubbles) – packaging risk (2020)

This recall involves Crafty Bubbles Wintergreen Essential oil in amber 15 mL and 100 mL bottles with a black continuous thread cap. "Crafty Bubbles," "Wintergreen Essential Oil" and the volume amount are printed on the white label on the front of each bottle.

CPSCNov 10, 2020Nationwide• Bolek's Craft Supplys Inc., of Dover, Ohio

Helena Laboratories, Corp.: K-ACT Actalyke Clotting Test Tubes that are used in the: ...

Due to complaints received associated with cracked/split test tube caps.

FDANov 9, 2020Nationwide• Helena Laboratories, Corp.

Premium Apple Cider (Giant) – processing error (2020)

Processing error resulting in mixing of pasteurized and raw cider into final product.

Class IIModerate

FDANov 9, 2020MD, MA, MI• Mayer Brothers Apple Products, Inc.

Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom: Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product U...

During system upgrade incorrect comments may be added to existing tests. In such instance: Resting ECG and ABP tests which did not contain comments at the time of the upgrade, may have unrelated comments added. Existing comments will not be overwritten or removed. Rhythm ECG Tests may have comments overwritten with unrelated comments. Any tests created after the upgrade are not affected.

FDANov 6, 2020Nationwide• Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom

Clomipramine Capsules (Jubilant) – Specification Failure (2020)

Failed Tablet/Capsule Specification

Class IIModerate

FDANov 6, 2020Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Boston Scientific Corporation: EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSoni...

This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower temperatures. All EKOS CU 4.0 consoles containing the old RF board design will be replaced with the newly designed CU 4.0 consoles.

FDANov 3, 2020Nationwide• Boston Scientific Corporation

Elderberries Whole Organic (Natural Grocers) – Salmonella Risk (2020)

Salmonella

Potential contamination with Salmonella.

Class IIModerate

FDAOct 27, 2020AZ, AR, CO +17 more• Vitamin Cottage Natural Foods Market, Inc DBA Natural Grocers