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ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom

ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom Recalls

All product recalls associated with ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom.

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Recall Summary

Total Recalls

1000

Past Year

582

Class I (Serious)

Most Recent

Dec 2025

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 1661–1680 of 10937 recalls

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

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

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Moderate

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

MICRO-X Rover Mobile X-ray System (Micro-X) – Exposure Time Limitation (2023)

Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.

Moderate

FDAMay 31, 2023Nationwide• Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia

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

Tobasi Cheese (Cricket Creek Farm) – Listeria Contamination (2023)

Listeria

Products may be contaminated with Listeria monocytogenes.

Class IIModerate

FDAMay 25, 2023CT, MA, NY• Cricket Creek Farm LLC

Feta Cheese (Cricket Creek Farm) – Pasteurization Issue (2023)

Products were not properly pasteurized.

Class IIModerate

FDAMay 25, 2023CT, MA, NY• Cricket Creek Farm LLC

Sophelise Cheese (Cricket Creek Farm) – Listeria Contamination (2023)

Listeria

Products may be contaminated with Listeria monocytogenes.

Class IHigh

FDAMay 25, 2023CT, MA, NY• Cricket Creek Farm LLC

Berkshire Bloom Cheese (Cricket Creek Farm) – Pasteurization Issue (2023)

Products were not properly pasteurized.

Class IIModerate

FDAMay 25, 2023CT, MA, NY• Cricket Creek Farm LLC

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

Hemospray Endoscopic Hemostat: Reference Part Numbers: ... (Wilson-Cook Medical Inc.) – there are potential risks of the hemo... (2023)

There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.

Moderate

FDAMay 22, 2023Nationwide• Wilson-Cook Medical Inc.

Phenylephrine HCl Sodium Chloride Bag (New England Life Care) – Product Mix-up (2023)

Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride

Class IIILow

FDAMay 22, 2023Nationwide• New England Life Care, Inc. dba Advanced Compounding Solutions

Brown Sugar Chunk Ice Cream (Van Leeuwen) – Undeclared Walnuts (2023)

Undeclared Allergen

Product may contain undeclared walnuts.

Class IHigh

FDAMay 22, 2023CT, ME, MD +7 more• Van Leeuwen Ice Cream LLC

PhysiciansCare Allergy Tablets (Acme United) – medication issue (2023)

This recall involves PhysiciansCare brand Allergy caplets with item number 90036, Allergy Plus tablets with item number 90091, and Cold and Cough tablets with item numbers 90092 and 90033. They are packaged in boxes of 50, 100 and 250 tablets/caplets. The item numbers are printed on the top right corner of the box. The recall includes the following: Item Number Description 90036 PhysiciansCare Allergy; 50 caplets 90091 PhysiciansCare Allergy Plus; 100 tablets Non-Drowsy Cold and Cough; 100 tablets 90033 PhysiciansCare Cold and Cough; 250 tablets

High

CPSCMay 18, 2023Nationwide• Acme United, of Rocky Mount, North Carolina

QUADROX-iD (Maquet) – Packaging Accessory Damage (2023)

1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory s sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

Very High

FDAMay 18, 2023Nationwide• Maquet Medical Systems USA

QUADROX-iR (Maquet) – Packaging Accessory Damage (2023)

1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

Very High

FDAMay 18, 2023Nationwide• Maquet Medical Systems USA

QUADROX-iD Pediatric (Maquet) – Packaging Pinhole Risk (2023)

Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.

Very High

FDAMay 18, 2023Nationwide• Maquet Medical Systems USA

QUADROX-i Adult (Maquet) – Packaging Pinhole Risk (2023)

Very High

FDAMay 18, 2023Nationwide• Maquet Medical Systems USA

QUADROX-i Adult (Maquet) – Packaging Accessory Damage (2023)

Very High

FDAMay 18, 2023Nationwide• Maquet Medical Systems USA