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Showing 2741–2760 of 4423 results

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Sulfamethoxazole Trimethoprim Tablets (Amneal) – Microbial Contamination (2025)

Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.

FDAJun 2, 2025Nationwide• Amneal Pharmaceuticals, LLC

Lidocaine HCL Sterile Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Ford F-550 (Custom Truck) – Electrical Node Failure Risk (2025)

Fire/Burn Risk

Custom Truck and Body Works (Custom Truck) is recalling certain 2020 Ford F-550 vehicles equipped with Weldon 8X16 Input-Output nodes. In the event of a short circuit or wiring failure, the firmware in the node may fail to shut off the output pin, resulting in overloaded electrical circuits.

High

NHTSAJun 2, 2025Nationwide• CUSTOM TRUCK & BODY WORKS

Lidocaine HCL with Epinephrine Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Ketamine Hydrochloride 50mg Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Lidocaine HCl Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Bupivacaine HCL Sterile Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Ketamine Hydrochloride Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Eudos Bronquilan (Nature's Eudos) – Undeclared Colors (2025)

Undeclared Allergen

Undeclared colors (FD&C Yellow #5, FD&C Blue #1, and FD&C Red #40)

Class IIModerate

FDAJun 1, 2025NJ, NY• Nature's Eudos Distributors LLC

Collins School Bus (Forest River) – Emergency Exit Failure (2025)

Forest River Bus, LLC (Forest River Bus) is recalling certain 2023-2027 Collins Bus school buses. The lock on the emergency exit door may fail to unlock. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 217, "Bus Emergency Exits and Window Retention and Release."

NHTSAMay 30, 2025Nationwide• FOREST RIVER BUS

Collins Bus (Forest River) – Emergency Exit Failure (2025)

Forest River Bus, LLC (Forest River Bus) is recalling certain 2025 Collins Bus transit buses. The lock on the emergency exit door may fail to unlock. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 217, "Bus Emergency Exits and Window Retention and Release."

NHTSAMay 30, 2025Nationwide• FOREST RIVER BUS

Servo-n Ventilator (Maquet) – Patient Circuit Test Error (2025)

Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.

FDAMay 30, 2025Nationwide• Maquet Critical Care AB Rontgenvagen

Icosapent Ethyl Capsules (Zydus) – Burnt Capsules (2025)

Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.

Class IIModerate

FDAMay 30, 2025IL, MS, PA• Zydus Pharmaceuticals (USA) Inc

Testo-200 Testosterone Injection (Advanced Pharma) – Unapproved Product (2025)

Marketed Without an Approved NDA/ANDA

Class IIModerate

FDAMay 30, 2025NJ, NY• Advanced Pharmaceutical Technology, Inc.

Mercedes-Benz GLE 350 4MATIC (Mercedes-Benz) – Mirror Visibility Problem (2025)

Mercedes-Benz USA, LLC (MBUSA) is recalling certain 2024 GLE 350 4MATIC, 2025 GLE 450e 4MATIC, GLE 450 4MATIC Coupe, GLE 450 4MATIC, GLS 450 4MATIC, Maybach GLS 600 4MATIC, AMG GLE 53 4MATIC, AMG GLE 53 4MATIC Coupe, AMG GLE 63 S 4MATIC Coupe, and AMG GLS 63 4MATIC vehicles. The multi-purpose camera and the rearview mirror may be insufficiently attached to the windshield and may detach.

NHTSAMay 30, 2025Nationwide• MERCEDES-BENZ

Servo-u MR Ventilator (Maquet) – Patient Circuit Test Error (2025)

Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.

FDAMay 30, 2025Nationwide• Maquet Critical Care AB Rontgenvagen

Orange EV E-Triever (Orange EV) – Steering Fastener Issues (2025)

Orange EV is recalling certain 2023-2025 HUSK-e, e-TRIEVER, and 2022-2024 T-Series trucks. The bolts securing the upper steering shaft clamp may have been improperly tightened.

NHTSAMay 30, 2025Nationwide• ORANGE EV

Inseego USB8 4G Dongle Kit (Remote Diagnostic) – Outdated Software (2025)

Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia due to unexpected loss of video laryngoscopy and all other monitor measurements during system restart.

FDAMay 30, 2025Nationwide• Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom

Platelia Toxo IgM (Bio-Rad) – False Positive Results (2025)

Due to a risk of false positive results that could lead to unnecessary medical treatment.

FDAMay 30, 2025Nationwide• Bio-Rad Laboratories, Inc.

Hillrom Q-Link 13 Component (Baxter Healthcare) – False Attachment Risk (2025)

The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.

FDAMay 30, 2025Nationwide• Baxter Healthcare Corporation

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