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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

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 2761–2780 of 37665 recalls

Access Cortisol Assay (Beckman Coulter) – Calibration Curve Error (2024)

The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance parameter at the S1 calibrator level that can lead to a high rate of calibration failures which can vary by reagent lot number. Calibration failure would lead to delay of measurement results reporting and potential injuries.

Moderate

FDASep 30, 2024Nationwide• Beckman Coulter, Inc.

El Gallo Azul Processed Cheese (Yucatan Products) – Non-English Labeling (2024)

Non-English labeling

Class IIModerate

FDASep 30, 2024OR• Yucatan Products dba Lorena Sandoval

Hungarian Mushroom Soup (Puget Consumers Co-Op) – Larvae Presence (2024)

Product is recalled due to possible presence of larvae.

Class II

1...137 138139140 141...1884

Page 139 of 1884Next

Moderate

FDASep 30, 2024IN, WA• Puget Consumers Co-Op

Ascorbic Acid Injection (Staska) – Glass Particulates (2024)

Presence of Particulate Matter: Presence of glass particulates.

Class IHigh

FDASep 30, 2024Nationwide• Staska Pharmaceuticals, Inc.

IMMULITE 2000 PSA Assay (Siemens) – High-Dose Hook Effect Issue (2024)

The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU).

Moderate

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

Precice Max Femur Implant (NuVasive) – Design and Manufacturing Issue (2024)

Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.

Moderate

FDASep 30, 2024FL, NV• NuVasive Specialized Orthopedics, Inc.

Westby Cheese Curds (Westby Cooperative Creamery) – E. Coli Risk (2024)

E. coli

Cheese curds may be contaminated with generic E. coli.

Class IIModerate

FDASep 29, 2024WI• Westby Cooperative Creamery

Westby Pepper Cheese Curds (Westby Cooperative Creamery) – E. Coli Risk (2024)

E. coli

Cheese curds may be contaminated with generic E. coli.

Class IIModerate

FDASep 29, 2024WI• Westby Cooperative Creamery

King Harvest Spinach Hummus (Pacific Coast Fresh) – Plastic Fragment Risk (2024)

Recall initiated due to potential plastic fragments.

Class IIModerate

FDASep 28, 2024IN, OR, WA• Pacific Coast Fresh CO

Viking Travel Trailer (VIKING) – Roof Rack Hardware Problem (2024)

Forest River, Inc. (Forest River) is recalling certain 2024-2025 Viking and Clipper travel trailers. The roof rack hardware may not have been properly tightened, allowing the rack to detach from the roof.

Moderate

NHTSASep 27, 2024Nationwide• VIKING TRAVEL TRAILERS

Flex Extenders (Westmed) – Connector Connection Force Problem (2024)

Due to connector within the circuit flex extender not meeting specifications resulting in a low connection force and as a result, the connector may leak or disconnect and may cause life threating conditions or death.

Very High

FDASep 27, 2024AK, CA, CO +27 more• Westmed, Inc.

Forest River Clipper Camping Trailer (FOREST RIVER) – Side Marker Light Defect (2024)

Forest River, Inc. is recalling certain 2024-2025 Viking and Clipper travel trailers. The side marker lights may not reflect light as intended, which can make it difficult for other drivers to see the trailer. As such, these trailers fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, "Lamps, Reflective Devices, and Associated Equipment."

Moderate

NHTSASep 27, 2024Nationwide• FOREST RIVER

King LTSD Size 2 (King Systems) – Pediatric Use Risk (2024)

Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

Moderate

FDASep 26, 2024Nationwide• King Systems Corp. dba Ambu, Inc.

King LTSD Size 1 (King Systems) – Pediatric Use Risk (2024)

Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

Moderate

FDASep 26, 2024Nationwide• King Systems Corp. dba Ambu, Inc.

King LTSD Size 0,1 (King Systems) – Pediatric Use Risk (2024)

Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

Moderate

FDASep 26, 2024Nationwide• King Systems Corp. dba Ambu, Inc.

Tesla Cybertruck (Tesla) – Camera Delay (2024)

Tesla, Inc. (Tesla) is recalling certain 2024 Cybertruck vehicles. The rearview camera image may be delayed after shifting into reverse. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 111, "Rear Visibility."

Moderate

NHTSASep 26, 2024Nationwide• TESLA

King LTSD Airway Kit (King Systems) – Pediatric Use Limitation (2024)

Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

Moderate

FDASep 26, 2024Nationwide• King Systems Corp. dba Ambu, Inc.

Duraform Dural Graft Implant (Integra) – Endotoxin Levels (2024)

Out of specification endotoxin levels.

Moderate

FDASep 26, 2024Nationwide• Integra LifeSciences Corp.

King LTSD Size 2.5 (King Systems) – Pediatric Use Risk (2024)

Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.

Moderate

FDASep 26, 2024Nationwide• King Systems Corp. dba Ambu, Inc.

Elekta Biopsy Needle Kit (Elekta) – Microscopic Debris (2024)

Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles.

Moderate

FDASep 25, 2024AZ, CA, FL +8 more• Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden