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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

730

Class I (Serious)

175

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 1721–1740 of 11124 recalls

Ringed DxI Reaction Vessels (Beckman Coulter) – System Compatibility (2023)

Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immunoassay System (600, 800 series). The reason for the recall is that the firm has identified 3 lots of RVs that failed an internally used service test to evaluate washing efficiency. Increased relative light units (RLU) suspected to be caused by the resulting rough interior surface may lead to artificially falsely elevated results for susceptible tests, in particular, sandwich assays including, but not limited to, hsTnI, Hybritech p2PSA, IPTH/IPTH IO.

Moderate

FDAJun 20, 2023Nationwide• Beckman Coulter, Inc.

Smoked Salmon Spread (Kenai Red Fish) – Allergen Mislabeling (2023)

The ingredients Statement declares Salmon, Marscapone, Cream Cheese, and Worchester Sauce. The Contains statement declares Fish and Milk but it does not declare Anchovies and Salmon.

Class IIILow

FDAJun 14, 2023IN, OR• Kenai Red Fish Company LLC

Original Eye Drops (K.C. Pharmaceuticals) – Manufacturing Documentation (2023)

1...85 868788 89...557

Page 87 of 557Next

CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.

Class IIModerate

FDAJun 13, 2023Nationwide• K.C. Pharmaceuticals, Inc

Dry Eye Relief Drops (K.C. Pharmaceuticals) – Manufacturing Documentation (2023)

CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.

Class IIModerate

FDAJun 13, 2023Nationwide• K.C. Pharmaceuticals, Inc

Sterile Ultrasound Gel (Turkuaz) – Sterility Concern (2023)

Sterility of Ultrasound gel can not be guaranteed.

Moderate

FDAJun 9, 2023IL• Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S. Akcaburgaz Mahallesi Muhsin Yazicioglu Caddesi No:45/5 Esenyurt Turkey

BD Synapsys Informatics Solution (Becton Dickinson) – Patient Data Mis-association (2023)

There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operating near capacity and are using save actions (Skip, Final Discard, Mark as Read, Save) to process patient results rapidly.

Moderate

FDAJun 8, 2023CA, CO, IL +12 more• Becton Dickinson & Co.

Catalyft LS Interbody System (Medtronic) – Geometry Specification Issue (2023)

There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

Moderate

FDAJun 6, 2023Nationwide• Medtronic Sofamor Danek USA Inc

VITROS Troponin I ES Reagent (ORTHO-CLINICAL) – Incorrect Wells (2023)

Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.

Moderate

FDAJun 5, 2023Nationwide• ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom

DxA Automation System (Beckman Coulter) – Test Sample Compatibility (2023)

A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results

Moderate

FDAJun 2, 2023AL, CA, FL +16 more• Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany

Fanta Orange 12pk (Coca-Cola) – Incorrect sugar labeling (2023)

Immediate package labeled as zero sugar contains the full sugar variety

Class IIModerate

FDAJun 1, 2023CA• Great Lakes Coca-Cola Distribution LLC

UFSK Treatment Chair 500 XLE (UFSK) – Drive Mechanism Wear (2023)

Service life of the electrical seat part drive of the treatment chair may be shortened unexpectedly after several years of use due to a potential wear-related reduction in the self-locking of the drive and may remain undetected. A worsened self-locking of the seat drive can lead to overriding the drive s end position when positioning the patient with the seat part in an inclined position

Moderate

FDAMay 31, 2023Nationwide• UFSK International OSYS Gmbh Kirchhoffstr. 1 Ratisbon Germany

COULTER DxH Diluent (Beckman Coulter) – Specification Deviation (2023)

Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.

Moderate

FDAMay 31, 2023Nationwide• Beckman Coulter, Inc.

Chocolate Peanut Butter Ice Cream (Tillamook) – Undeclared Wheat, Soy (2023)

Undeclared Gluten

Undeclared Wheat and Soy. Waffle Cone Swirl Ice Cream was mistakenly packaged in Chocolate Peanut Butter cartons with the correct Waffle Cone Swirl lids. Waffle Cone Swirl ice cream contains wheat and soy which are not declared on the Chocolate Peanut Butter label.

Class IIModerate

FDAMay 27, 2023ID, IN, WA• Tillamook County Creamery Association

Knapheide RAM 3500 (KNAPHEIDE) – Winch Equipment Issue (2023)

Knapheide Manufacturing Company (KMC) is recalling certain 2022-2023 GM 2500HD, 2022 RAM 3500, Ford F-250, F-350, F-550, and 2023 GM 3500 vehicles equipped with certain Warn Industries VR EVO winches with a wireless handheld remote. Water may enter the handheld remote control for the winch and cause circuit board corrosion, which can allow the winch to operate unintentionally.

Moderate

NHTSAMay 26, 2023Nationwide• KNAPHEIDE

Keystone Arcadia (KEYSTONE) – Structural Cabinet Issue (2023)

Keystone RV Company (Keystone) is recalling certain 2021-2023 Arcadia travel trailers. The backer board behind the cabinet for the wardrobe may not have been installed during production.

Moderate

NHTSAMay 26, 2023Nationwide• KEYSTONE

Penne Rigate Mozzarella Salad (Wegmans) – Undeclared Milk (2023)

Undeclared Allergen

Undeclared milk allergen

Class IIModerate

FDAMay 25, 2023IN, MA, NY +1 more• ASK Foods Inc

RET Distal Probe. Used in Fluorescence in situ hybridizat... (Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom) – dnas used during the manufacture of t... (2023)

DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.

Low

FDAMay 24, 2023Nationwide• Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom

RET Proximal Probe. Used in Fluorescence in situ hybridiz... (Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom) – dnas used during the manufacture of t... (2023)

DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.

Low

FDAMay 24, 2023Nationwide• Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom

2022 KIDRON REFRIGERATED TRAILER – st engineering hackney, inc (2023)

ST Engineering Hackney, Inc. (STE Hackney) is recalling certain 2021-2023 Kidron refrigerated trailers. The suspension pivot bolt may not have been properly tightened during the alignment process on certain Hendrickson suspensions with Quick-Align systems.

High

NHTSAMay 24, 2023Nationwide• KIDRON

Power-PRO 2- A powered ambulance cot that consists of a p... (Stryker Medical Division of Stryker Corporation) – base leg assembly may bend and result... (2023)

Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficulty loading/unloading from ambulance, difficulty raising or lowering the cot, cot tip, or erratic or unintended motion.

Low

FDAMay 24, 2023Nationwide• Stryker Medical Division of Stryker Corporation