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Beckman Coulter Inc.

Beckman Coulter Inc. Recalls

All product recalls associated with Beckman Coulter Inc..

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Recall Summary

Total Recalls

1000

Past Year

899

Class I (Serious)

125

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 161–180 of 17592 recalls

SYNCHRON LDL Cholesterol Reagent (Beckman Coulter) – Test Accuracy Issue (2025)

Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally and confirmed on August 19, 2025 by Beckman Coulter.

Moderate

FDASep 17, 2025Nationwide• Beckman Coulter Inc.

Phenylephrine HCI (Park Avenue) – CGMP Deviation (2025)

CGMP Deviations

Class IIModerate

FDASep 17, 2025MO• Park Avenue Compounding

Sentinel V11 (Spacelabs) – Patient Data Mishandling (2025)

Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions, test data intended for one patient may be saved under another patient's record

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Moderate

FDASep 16, 2025Nationwide• Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom

Dried Bean Curd (G&L Food) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared allergen (wheat).

Class IIILow

FDASep 16, 2025CA• Gansu Zhaofeng Agricultural Development Co., Ltd.

Oxytocin IV Solution (IntegraDose) – No Active Ingredient (2025)

Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.

Class IHigh

FDASep 16, 2025Nationwide• IntegraDose Compounding Services LLC

Catalyft Interbody System (Medtronic) – Cage Height Collapse Risk (2025)

Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.

Moderate

FDASep 16, 2025Nationwide• Medtronic Sofamor Danek USA Inc

FDR Visionary Suite (Fujifilm) – X-ray Support Defect (2025)

It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.

Moderate

FDASep 15, 2025AK, CA, FL +5 more• FUJIFILM Healthcare Americas Corporation

Bupropion XL Tablets (Graviti) – Tablet Specification Failure (2025)

Failed Tablet/Capsule Specifications

Class IIModerate

FDASep 15, 2025Nationwide• Graviti Pharmaceuticals Private Limited

Mixed Nuts Salted (Severn Peanut) – Undeclared Nut (2025)

Undeclared Allergen

Undeclared Tree Nut. The firm discovered that Hazelnuts was not listed in the allergen statement

Class IIModerate

FDASep 15, 2025MA, NY• Severn Peanut Company LLC

Mixed Nuts No Salt (Severn Peanut) – Undeclared Nut (2025)

Undeclared Allergen

Undeclared Tree Nut. The firm discovered that Hazelnuts was not listed in the allergen statement

Class IIModerate

FDASep 15, 2025MA, NY• Severn Peanut Company LLC

Millenium MPR (GE Medical) – Service End Risk (2025)

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

Very High

FDASep 12, 2025Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel