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Flexicare Medical (Dongguan) Ltd. Hengli Town No. B-15 Xicheng; Henglizhen Dongguan China

Flexicare Medical (Dongguan) Ltd. Hengli Town No. B-15 Xicheng; Henglizhen Dongguan China Recalls

All product recalls associated with Flexicare Medical (Dongguan) Ltd. Hengli Town No. B-15 Xicheng; Henglizhen Dongguan China.

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Recall Summary

Total Recalls

1000

Past Year

620

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 261–280 of 10937 recalls

BritePro Solo Handle (Flexicare) – Illumination Failure (2025)

Laryngoscope handles may not illuminate as intended.

FDAJul 11, 2025Nationwide• Flexicare Medical (Dongguan) Ltd. Hengli Town No. B-15 Xicheng; Henglizhen Dongguan China

Plum Duo Infusion System (ICU Medical) – Interface Problem (2025)

ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.

FDAJul 11, 2025Nationwide• ICU Medical, Inc.

Britepro Solo Stubby Handle (Flexicare) – Illumination Failure (2025)

Laryngoscope handles may not illuminate as intended.

FDAJul 11, 2025Nationwide

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• Flexicare Medical (Dongguan) Ltd. Hengli Town No. B-15 Xicheng; Henglizhen Dongguan China

Micro Joystick R-net (mo-Vis) – Software Timing Error (2025)

Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.

FDAJul 10, 2025Nationwide• mo-Vis BVBA Biebuyckstraat 15D Nevele Belgium

Vercise Brain Stimulation System (Boston Scientific) – Wire Break Risk (2025)

Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges.

FDAJul 8, 2025Nationwide• Boston Scientific Neuromodulation Corporation

Burr Hole Cover Kit (Boston Scientific) – Clip Locking Problem (2025)

Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may require additional surgery.

FDAJul 8, 2025Nationwide• Boston Scientific Neuromodulation Corporation

BD Trucount Controls (BD Bio Sciences) – Incorrect SD Values (2025)

Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.

FDAJul 8, 2025Nationwide• Becton, Dickinson and Company, BD Bio Sciences

Reading Rail Gear Trucks HD (Reading) – Weld Crack Risk (2025)

Reading Truck Body, LLC (Reading) is recalling certain 2021 Rail Gear HD trucks. Welds may crack and fail, allowing the front rail gear to shift and contact the road.

NHTSAJul 7, 2025Nationwide• READING TRUCK EQUIPMENT

GE OEC 9800 (GE Medical Systems) – Regulatory Non-Conformance (2025)

GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.

FDAJul 2, 2025Nationwide• GE Medical Systems, LLC