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

1000

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 1921–1940 of 21320 recalls

WallFlex ESO Stent 23x105mm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

High

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Bikano Moong Dal (Thal Golden Spices) – salmonella risk (2024)

Salmonella

Potential Salmonella contamination.

Class IHigh

FDAAug 1, 2024CA, IN• Thal Golden Spices Inc.

Methotrexate Tablets (Amneal) – Foreign Tablet Contamination (2024)

Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.

Class III

1...95 969798 99...1066

Page 97 of 1066Next

Low

FDAAug 1, 2024Nationwide• Amneal Pharmaceuticals, LLC

WallFlex ESO Stent LL 18x103 (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

High

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Agile ESO OTW PC 23mm 12.0cm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

High

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Agile ESO OTW PC 23mm 15.0cm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

High

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Silver-Plated Copper Sims Uterine Sound (CooperSurgical) – Incorrect Part Number (2024)

During the manufacturing process the devices were laser-marked with the incorrect part number.

Low

FDAJul 31, 2024Nationwide• CooperSurgical, Inc.

Inspire Model 4063 Stimulation Lead (Inspire) – Labeling Error (2024)

Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.

Low

FDAJul 31, 2024Nationwide• Inspire Medical Systems Inc.

Stainless Steel Sims Uterine Sound (CooperSurgical) – Incorrect Part Number (2024)

During the manufacturing process the devices were laser-marked with the incorrect part number.

Low

FDAJul 31, 2024Nationwide• CooperSurgical, Inc.

MiniMed 630G (Medtronic) – Physical Impact Damage (2024)

Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.

High

FDAJul 31, 2024AL, AK, AZ +49 more• Medtronic MiniMed, Inc.

Indomethacin Capsules (Glenmark) – Dissolution Specification Failure (2024)

Failed Dissolution Specifications: below specification results

Class IIModerate

FDAJul 31, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Gabapentin Tablets (Granules) – Foreign Tablet Contamination (2024)

Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets

Class IIModerate

FDAJul 31, 2024Nationwide• Granules Pharmaceuticals Inc.

MiniMed 670G (Medtronic) – Physical Impact Damage (2024)

High

FDAJul 31, 2024AL, AK, AZ +49 more• Medtronic MiniMed, Inc.

MiniMed 620G (Medtronic) – Physical Impact Damage (2024)

High

FDAJul 31, 2024AL, AK, AZ +49 more• Medtronic MiniMed, Inc.

Inspire Model 4340 Respiratory Sensing Lead (Inspire) – Labeling Error (2024)

Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.

Low

FDAJul 31, 2024Nationwide• Inspire Medical Systems Inc.

Dimension Vista TBIL Reagent (Siemens) – Testing Limitation (2024)

During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an issue with the filling line which led to some wells to underfill in lot 23206BA. Calibrator, quality control (QC) and patient results could have been impacted.

Moderate

FDAJul 30, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

ADVIA Chemistry UCFP (Siemens) – Quality Control Bias (2024)

The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.

Moderate

FDAJul 29, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CH UCFP (Siemens) – Quality Control Bias (2024)

The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.

Moderate

FDAJul 29, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Van Leeuwen Vegan Oat Dessert – undeclared peanuts (2024)

Undeclared Allergen

Undeclared peanuts (allergen)

Class IHigh

FDAJul 29, 2024NY• Van Leeuwen Ice Cream LLC

Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use i... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (2024)

Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.

Moderate

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.