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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

1000

Class I (Serious)

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 3941–3960 of 21320 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

Perifix Epidural Kit (B. Braun) – Incorrect Filter Straw (2023)

Kits were assembled with the incorrect Filter Straw.

Moderate

FDAJun 5, 2023Nationwide• B. Braun Medical, Inc.

Design Options Epidural Kit (B. Braun) – Incorrect Filter Straw (2023)

Kits were assembled with the incorrect Filter Straw.

Moderate

FDAJun 5, 2023Nationwide

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• B. Braun Medical, Inc.

IC Bus CESB (IC BUS) – Brake Fluid Leakage (2023)

Fire/Burn Risk

Navistar, Inc. (Navistar) is recalling certain 2016 and 2018-2024 IC Bus CE school buses. The brake pressure switch assembly may leak brake fluid into the brake pressure switch's electrical components and cause an electrical short-circuit.

High

NHTSAJun 2, 2023Nationwide• IC BUS

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

Megadyne MEGA SOFT Universal Electrode (Megadyne) – Patient Burn Risk (2023)

Fire/Burn Risk

Firm has received reports of patient burns in surgical procedures where device was used.

High

FDAJun 1, 2023Nationwide• Megadyne Medical Products, Inc.

Megadyne MEGA 2000 Electrode (Megadyne) – Patient Burn Risk (2023)

Fire/Burn Risk

Firm has received reports of patient burns in surgical procedures where device was used.

High

FDAJun 1, 2023Nationwide• Megadyne Medical Products, Inc.

Epoc BGEM Crea Test Card (Siemens) – Glucose Result Discrepancy (2023)

There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.

Moderate

FDAJun 1, 2023AL, AZ, AR +23 more• Siemens Healthcare Diagnostics Inc

Megadyne MEGA SOFT Reusable Electrode (Megadyne) – Patient Burn Risk (2023)

Fire/Burn Risk

Firm has received reports of patient burns in surgical procedures where device was used.

High

FDAJun 1, 2023Nationwide• Megadyne Medical Products, Inc.

Epoc BGEM Veterinary Test Card (Siemens) – Glucose Result Discrepancy (2023)

There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.

Moderate

FDAJun 1, 2023AL, AZ, AR +23 more• Siemens Healthcare Diagnostics Inc

Epoc BGEM BUN Test Card (Siemens) – Glucose Result Discrepancy (2023)

There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.

Moderate

FDAJun 1, 2023AL, AZ, AR +23 more• Siemens Healthcare Diagnostics Inc

Megadyne MEGA SOFT Dual Electrode (Megadyne) – Patient Burn Risk (2023)

Fire/Burn Risk

Firm has received reports of patient burns in surgical procedures where device was used.

High

FDAJun 1, 2023Nationwide• Megadyne Medical Products, Inc.

Megadyne MEGA SOFT Universal Dual Electrode (Megadyne) – Patient Burn Risk (2023)

Fire/Burn Risk

Firm has received reports of patient burns in surgical procedures where device was used.

High

FDAJun 1, 2023Nationwide• Megadyne Medical Products, Inc.

Megadyne MEGA SOFT Pediatric Electrode (Megadyne) – Patient Burn Risk (2023)

Fire/Burn Risk

Firm has received reports of patient burns in surgical procedures where device was used.

High

FDAJun 1, 2023Nationwide• Megadyne Medical Products, Inc.

Trexo Device (Trexo Robotics) – Electrical Functionality Risks (2023)

Fire/Burn Risk

Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when in use.

High

FDAMay 31, 2023Nationwide• Trexo Robotics Holdings Inc.

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

Ziprasidone Hydrochloride Capsules (Harvard Drug Group) – Label Mix-up (2023)

Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.

Class IHigh

FDAMay 31, 2023Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

VERITAS Infusion Packs (Johnson & Johnson) – Housing Weld Defect (2023)

Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.

Moderate

FDAMay 30, 2023Nationwide• Johnson & Johnson Surgical Vision, Inc.

Extended Phenytoin Sodium Capsules (Amneal) – Dissolution Failure (2023)

Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)

Class IIModerate

FDAMay 30, 2023LA, OH, PA• Amneal Pharmaceuticals of New York, LLC

Amphotericin B Liposome Injection (Sun Pharmaceutical) – Subpotent Drug (2023)

Subpotent drug

Class IIModerate

FDAMay 30, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC