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Showing 401–420 of 35905 results

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Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. (Cepheid) – product testing did not meet expected... (2025)

Product testing did not meet expected stability criteria.

FDANov 5, 2025Nationwide• Cepheid

Hollandia Appleberry Juice (Hollandia Dairy) – Cleaning Solution (2025)

100% Appleberry Juice contaminated with cleaning solution, Peracetic Acid.

Class IIModerate

FDANov 5, 2025IN• Hollandia Dairy, Inc.

Bendix EC80 ECU (Bendix) – Brake Control Unit Issue (2025)

Bendix Commercial Vehicle Systems, LLC (Bendix) is recalling certain Bendix EC80 Advanced Electronic Control Units (ECU) part numbers K219877SC001, K219876SC001, K212565SC001, K168425SC000, K168424SC000, K168128R000, K168122R000, K271501R000, K271500R000, K16849SC000, K168421SC000, K168422SC000, K168423SC000, K209617SC000, K209615SC000, K212562SC000, and K212563SC000. Electrical noise and low signal to the power line carrier may cause the ECU to incorrectly process commands or stop working.

Moderate

NHTSANov 5, 2025Nationwide• BENDIX

Endera Shuttle (Endera) – Wheelchair Restraint Malfunction (2024)

Endera Motors (Endera) is recalling certain 2024-2026 Shuttle transit buses equipped with wheel chair restraint retractors. The retractors may not lock, preventing the wheelchair from being properly secured.

NHTSANov 5, 2025Nationwide• ENDERA

Sertraline Hydrochloride Tablets (Lupin) – defective container (2025)

Defective container - seal not adhering to bottles

Class IIModerate

FDANov 5, 2025Nationwide• Lupin Pharmaceuticals Inc.

Hemochron Activated Clotting Time Low-Range Test Cuvette,... (Accriva Diagnostics, Inc.) – foreign object (2025)

Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.

FDANov 5, 2025Nationwide• Accriva Diagnostics, Inc.

Oven Dried Fish (African Food on Wheels) – Botulinum Risk (2025)

Clostridium botulinum (uneviscerated fish)

FDANov 5, 2025IN, NY• African Food on Wheels Inc.

Onion Granules (Laiwu Manhing) – Foreign Objects (2025)

foreign objects (black plastic planting film) in granulated onion powder

Class IIModerate

FDANov 5, 2025CA• Laiwu Manhing Vegetables Fruits Co

Freightliner 108SD (Freightliner) – Suspension Fastener Issue (2020)

Daimler Trucks North America, LLC (DTNA) is recalling certain 2020-2026 Western Star 49X, Freightliner Business Class M2, Freightliner 114SD, Freightliner 108SD, 2021-2026 Western Star 47X, 2021-2023 Freightliner 122SD, 2022 Western Star 48X, and 2023 Western Star 4700 vehicles. The axle clamp fasteners may be loose, which can result in a loss of vehicle control.

NHTSANov 4, 2025Nationwide• FREIGHTLINER

Cardiosave Rescue. Intra-Aortic Balloon Pump system. (Datascope Corp.) – the ifu addendum revises the preventa... (2025)

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

FDANov 4, 2025Nationwide• Datascope Corp.

Spartan Fire Gladiator (Spartan Fire) – Door Latch Defect (2025)

Marion Body Works Inc. (Marion Body Works) is recalling certain 2024-2025 Spartan Fire FC-94, Gladiator, and Metrostar vehicles. The actuator lever arm in the cab door latch may bind or become wedged, preventing the door from opening.

NHTSANov 4, 2025Nationwide• SPARTAN FIRE

Organic Moringa Leaf Powder (Africa Imports) – Salmonella Contamination (2025)

Product tested positive for Salmonella.

FDANov 4, 2025AZ, CA, IA +11 more• Africa Imports

Cardiosave Hybrid. Intra-Aortic Balloon Pump system. (Datascope Corp.) – the ifu addendum revises the preventa... (2025)

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

FDANov 4, 2025Nationwide• Datascope Corp.

Estrogen & Progesterone Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Pregnancy Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

McNeilus Metro Pak Rear Loader (McNeilus) – Exterior Lighting Problem (2024)

McNeilus Truck & Manufacturing, Inc. (McNeilus) is recalling certain 2021-2025 Metro Pak vehicles. The side and rear reflex reflectors and rear clearance lights may be missing. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, "Lamps, Reflective Devices, and Associated Equipment."

NHTSANov 3, 2025Nationwide• MCNEILUS

Neurotransmitters Plus (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Neurotransmitters Basic (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Alcohol Test Saliva (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Trichomonas Vaginalis Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

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