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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 581–600 of 17592 recalls

DxI 9000 Access Analyzer (Beckman Coulter) – Calibration Issues (2025)

Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.

Moderate

FDAMay 7, 2025Nationwide• Beckman Coulter, Inc.

SmartRelease ESTR (MicroAire) – Unintended Blade Cut (2025)

Laceration Risk

Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.

High

FDAMay 7, 2025Nationwide• MicroAire Surgical Instruments, LLC

Bromfenac Ophthalmic Solution (Alembic) – Impurity Specification Failure (2025)

Failed Impurities/Degradation Specifications

Class II

1...28 293031 32...880

Page 30 of 880Next

Moderate

FDAMay 7, 2025Nationwide• Alembic Pharmaceuticals Limited

Simplera Sensor (Medtronic) – Sterility Compromise (2025)

The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.

High

FDAMay 7, 2025Nationwide• Medtronic MiniMed, Inc.

Powered Laser Surgical Instrument (Olympus) – Thermal Incident Risk (2025)

Fire/Burn Risk

Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.

High

FDAMay 6, 2025Nationwide• Olympus Corporation of the Americas

EVIS EXERA III Duodenovideoscope (Olympus) – Contamination Risk (2025)

Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.

Moderate

FDAMay 5, 2025Nationwide• Olympus Corporation of the Americas

Dexcom G7 iOS App (Dexcom) – Glucose Value Bug (2025)

A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated and that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycemic or hypoglycemic event or a treatment decision made based off incorrect data. There is no impact to transmitter communication with concurrently connected displays. A concurrently connected receiver, Apple Watch, and/or insulin pump will continue to receive EGVs directly from the transmitter when the app is in the problematic state. There is no impact to Automated Insulin Dosing (AID) therapy as the AID system continues to receive EGVs directly from the transmitter.

High

FDAMay 5, 2025Nationwide• Dexcom, Inc.

SAFE-T-FILL Capillary (ASP Global) – False Positive Results (2025)

All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare Testing Systems. False positive lead results may cause delayed results and additional unnecessary testing.

Moderate

FDAMay 5, 2025Nationwide• ASP Global, LLC. dba Anatomy Supply Partners, LLC.

Access Testosterone Assay (Beckman Coulter) – Maintenance Error (2025)

Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result in up to a 34% increase or a 23% decrease in patient results.

Moderate

FDAMay 5, 2025FL• Beckman Coulter, Inc.

LifeShield Infusion Software (ICU Medical) – Drug Library Defects (2025)

Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.

High

FDAMay 2, 2025Nationwide• ICU Medical, Inc.

Testosterone Cypionate Injection (Empower Pharmacy) – Sterility Risk (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2025Nationwide• Empower Clinic Services, LLC dba Empower Pharmacy

Canturio Smart Extension (Canary Medical) – Labeling Error (2025)

Due to labeling error. Product incorrectly labeled.

Low

FDAMay 2, 2025IN• Canary Medical, Inc.

Drill Stop Kit (Implant Direct) – Incorrect Components (2025)

The Drill stop kit contains incorrect components.

Moderate

FDAMay 1, 2025Nationwide• Implant Direct Sybron Manufacturing LLC

BX2 Needle Guide (Civco) – Probe Packaging Breach (2025)

During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.

Moderate

FDAMay 1, 2025GA• Civco Medical Instruments Co. Inc.

Sample Probe (Beckman Coulter) – Manufacturing Defect (2025)

A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and chamfered, which can prevent the proper formation of the "air layer" required for normal dispensing. The air layer is the air space that separates the cleaning water filled in the probe from the sample sucked into the probe. Maintaining this air space prevents the cleaning water and the sample from mixing. In the defective S probe, the "air layer" was not properly formed, causing the cleaning water and the sample to mix diluting the sample. As a result, the sample mixture dispensed into the cuvette has a lower concentration than the original sample, and the analyte concentration measured is lower than expected results.

Moderate

FDAApr 30, 2025Nationwide• Beckman Coulter Mishima K.K. 454-32 Higashino; Nagaizumi-Cho Sunto-Gun Japan

Cardiohelp System Wall Holder (Maquet) – Mounting Risk (2025)

HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.

High

FDAApr 30, 2025IL, MO• Maquet Cardiopulmonary Ag Kehler Str. 31 Rastatt Germany

NutriLean (Legere Pharmaceuticals) – Undeclared Colors (2025)

Undeclared Allergen

Undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No.1) used in gelatin capsules.

Class IIILow

FDAApr 30, 2025Nationwide• Preventics, Inc. dba Legere Pharmaceuticals

Super ProTHIN Plus (Legere Pharmaceuticals) – Undeclared Colors (2025)

Undeclared Allergen

Undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No.1) used in gelatin capsules.

Class IIILow

FDAApr 30, 2025Nationwide• Preventics, Inc. dba Legere Pharmaceuticals

Probese Caps (Legere Pharmaceuticals) – Undeclared Colors (2025)

Undeclared Allergen

Undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No.1) used in gelatin capsules.

Class IIILow

FDAApr 30, 2025Nationwide• Preventics, Inc. dba Legere Pharmaceuticals

Prothin Dietary Supplement (Legere Pharmaceuticals) – undeclared colors (2025)

Undeclared Allergen

Undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No.1) used in gelatin capsules.

Class IIILow

FDAApr 30, 2025Nationwide• Preventics, Inc. dba Legere Pharmaceuticals