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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

1000

Class I (Serious)

143

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 5761–5780 of 37665 recalls

EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Imp... (Boston Scientific Corporation) – there is a potential for a rare inter... (2023)

There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.

High

FDAJul 11, 2023Nationwide• Boston Scientific Corporation

Oxacillin Injection (Sagent) – sterility issue (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 11, 2023Nationwide• Sagent Pharmaceuticals

Oxacillin Injection (Sagent) – sterility risk (2023)

Lack of Assurance of Sterility

Class IIModerate

1...287 288289290 291...1884

Page 289 of 1884Next

FDA

Jul 11, 2023

Nationwide

• Sagent Pharmaceuticals

Fingolimod Capsules (Ascend) – dissolution failure (2023)

Failed Dissolution Specifications

Class IIModerate

FDAJul 11, 2023Nationwide• Ascend Laboratories, LLC

Oxacillin Injection (Sagent) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 11, 2023Nationwide• Sagent Pharmaceuticals

Big J Unbleached Flour (Big J Mill) – Potential filth (2023)

Flour may have filth.

Class IIILow

FDAJul 11, 2023IN, UT• Big J Mill & Elevator Company, Incorporated

Petite Misty Mints (Plantation Candies) – Undeclared soy (2023)

Undeclared Soy

Undeclared soy

Class IIModerate

FDAJul 11, 2023IN, MA, MI +3 more• Plantation Candies, Inc.

Golden Loaf Bakers Flour (Big J Mill) – Potential filth (2023)

Flour may have filth.

Class IIILow

FDAJul 11, 2023IN, UT• Big J Mill & Elevator Company, Incorporated

Atellica CH HDL Cholesterol- In vitro diagnostic use in ... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)

Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica CH Total Bilirubin_2 (TBil_2), Atellica CH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and Atellica CH HDL Cholesterol (HDLC)

Moderate

FDAJul 10, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnost... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)

Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from AtellicaCH Total Bilirubin_2 (TBil_2), Atellica CH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and Atellica CH HDL Cholesterol (HDLC)

Moderate

FDAJul 10, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CH LDL Cholesterol- In vitro diagnostic use in t... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)

Moderate

FDAJul 10, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

SurgiCount+ Software Application-indicated as an adjuncti... (Stryker Corporation) – potential for current software to mis... (2023)

Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type

Low

FDAJul 10, 2023Nationwide• Stryker Corporation

Trader Joes Broccoli Cheddar Soup (Winter Gardens) – Unspecified issue (2023)

Winter Gardens Quality Foods, 304 Commerce St., New Oxford, PA 17350 is initiating a recall of Trader Joes, Unexpected Broccoli Cheddar Soup , 20 oz. film sealed plastic container with lid, further packaged in cardboard case, keep refrigerated , because the product has insects in the frozen broccoli florets.

Class IIILow

FDAJul 10, 2023CA, CT, FL +4 more• Winter Gardens Quality Foods, Inc.

Hair-Skin-Nail Supplement (Emceta) – Labeling deficiency (2023)

FDA evaluation of Natural Systems brand HAIR - SKIN NAIL Dietary Supplement label disclosed several deficiencies to 21 CFR 101 Labeling Regulations.

Class IIILow

FDAJul 10, 2023Nationwide• Emceta International Inc.

Tiagabine Hydrochloride Tablets (Sun Pharma) – Impurity Failure (2023)

Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing

Class IIModerate

FDAJul 10, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Hand Sanitizer (Big Machine Distillery) – Impurity Excess (2023)

CGMP Deviation: impurities exceed allowable limits.

Class IIModerate

FDAJul 10, 2023TN• Tenn South Distillery LLC dba Big Machine Distillery

Multi Vitamin Supplement (Emceta) – Incorrect magnesium content (2023)

FDA sample analysis of Natural Systems brand Multi Vitamin, 60 Tablets, found the magnesium content as 33.5% of the amount declared in label.

Class IIILow

FDAJul 10, 2023Nationwide• Emceta International Inc.

Atellica CH Total Bilirubin_2 -In vitro diagnostic use in... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)

Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica CH Total Bilirubin_2 (TBil_2), AtellicaCH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and AtellicaCH HDL Cholesterol (HDLC)

Low

FDAJul 10, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

Five S 5 3x65, REF: 0915612-06, sterile for single use, S... (Karl Storz Endoscopy) – flexible intubation endoscopes steri... (2023)

Flexible intubation endoscopes sterility assurance can not be confirmed.

High

FDAJul 7, 2023Nationwide• Karl Storz Endoscopy

Norepinephrine IV Bag (SterRx) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 7, 2023Nationwide• SterRx, LLC