CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

Class IIModerate

FDAJul 11, 2025Nationwide• Nostrum Laboratories, Inc.

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

Laryngoscope handles may not illuminate as intended.

Moderate

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.

Moderate

FDAJul 11, 2025Nationwide• ICU Medical, Inc.

Blood/MacConkey Biplate (Remel) – Listeria Contamination (2025)

Listeria

The products may contain surface and subsurface contamination of Listeria monocytogenes.

Moderate

FDAJul 11, 2025Nationwide• Remel, Inc

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

Laryngoscope handles may not illuminate as intended.

Moderate

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

IDM-ARLITE-R (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.

High

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

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

High

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

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

High

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

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

High

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

IDM-MULTI-R (mo-Vis) – Software Timing Error (2025)

High

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

FilmArray NGDS Warrior Panel (Biofire Defense) – Control Failure (2025)

FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup.

Moderate

FDAJul 10, 2025Nationwide• Biofire Defense