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Showing 3181–3200 of 35916 results

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Valeda Light System (Lumithera) – Configuration Error (2025)

U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.

FDAMay 7, 2025Nationwide• LUMITHERA INC

SmartRelease ESTR (MicroAire) – Unintended Blade Cut (2025)

Laceration Risk

Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.

FDAMay 7, 2025Nationwide• MicroAire Surgical Instruments, LLC

Polestar 3 (Polestar) – Rearview Camera Malfunction (2025)

Polestar Automotive USA, Inc. (Polestar) is recalling certain Polestar 3 vehicles. The rearview camera image may not display when the vehicle is placed in reverse. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 111, "Rear Visibility."

Moderate

NHTSAMay 7, 2025Nationwide• POLESTAR

Z-800 Infusion System (Zyno Medical) – Unreleased Software (2025)

Unreleased software versions were installed on distributed devices without verification or validation.

FDAMay 7, 2025Nationwide• Zyno Medical LLC

OBM00002 OBM DAB (XLTEK) – Backwards Electrode Labels (2025)

Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device.

FDAMay 7, 2025Nationwide• Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

Z-800WF Infusion System (Zyno Medical) – Unreleased Software (2025)

Unreleased software versions were installed on distributed devices without verification or validation.

FDAMay 7, 2025Nationwide• Zyno Medical LLC

Aeromaster (Utilimaster) – Missing Seat Belts (2025)

Shyft Group (Shyft) is recalling certain 2025 Utilimaster Aeromaster vehicles. The rear seat belts may not have been installed. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 208, "Occupant Crash Protection."

NHTSAMay 7, 2025Nationwide• UTILIMASTER

Z-800F Infusion System (Zyno Medical) – Unreleased Software (2025)

Unreleased software versions were installed on distributed devices without verification or validation.

FDAMay 7, 2025Nationwide• Zyno Medical LLC

Bromfenac Ophthalmic Solution (Alembic) – Impurity Specification Failure (2025)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAMay 7, 2025Nationwide• Alembic Pharmaceuticals Limited

Audi Q5 (Audi) – Cylinder Head Cover Screws (2025)

Volkswagen Group of America, Inc. (Audi) is recalling certain 2022-2024 Q5 Quattro and Q5 Sportback Quattro vehicles. The cylinder head cover screws may have been improperly tightened.

NHTSAMay 7, 2025Nationwide• AUDI

Simplera Sensor (Medtronic) – Sterility Compromise (2025)

The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.

FDAMay 7, 2025Nationwide• Medtronic MiniMed, Inc.

Blue Bird School Bus (Blue Bird) – Seat Fastener Issue (2025)

Blue Bird Body Company (Blue Bird) is recalling certain 2026 Vision and All American school buses equipped with a lap belt-ready or 3-pt seats. The seat mounting fasteners may have been improperly tightened. As such, these vehicles fail to comply with Federal Motor Vehicle Safety Standard numbers 207, "Seating Systems," 210, "Seat Belt Assembly Anchorages," and 222, "School Bus Passenger Seating and Crash Protection."

NHTSAMay 6, 2025Nationwide• BLUE BIRD

Palisade (Hyundai) – Cooling System Defect (2025)

Hyundai Motor America (Hyundai) is recalling certain 2025 Hyundai Palisade vehicles. An insufficient seal on the controller for the electric oil pump may allow moisture to accumulate in the printed circuit board, which can cause an electrical short and result in a fire.

NHTSAMay 6, 2025Nationwide• HYUNDAI

HardyCHROM CRE (Hardy Diagnostics) – Quality Control Failure (2025)

Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.

FDAMay 6, 2025AZ, CA, CO +19 more• Hardy Diagnostics

PhenoMATRIX (Copan) – Unapproved Software (2025)

AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and may lead to inaccurate counts and/or morphology characteristics impacting patient diagnosis and subsequent care.

FDAMay 6, 2025Nationwide• Copan WASP Via Achille Grandi

Durango Gold (KZRV) – Step Assembly Mounting (2025)

K.Z., Inc. (KZRV) is recalling certain 2025 Durango Gold fifth wheels, equipped with a removable step assembly. The clip-on bracket mounting bolts may come loose, allowing the steps to detach.

NHTSAMay 6, 2025Nationwide• KZRV

Powered Laser Surgical Instrument (Olympus) – Thermal Incident Risk (2025)

Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.

FDAMay 6, 2025Nationwide• Olympus Corporation of the Americas

Affinity 4 Birthing Bed (Baxter) – Signal Wire Crimp (2025)

There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.

FDAMay 6, 2025Nationwide• Baxter Healthcare Corporation

Apple & PB Snack Cup (GBC Food Services) – Plastic Contamination (2025)

Foreign Material (plastic)

Class IIModerate

FDAMay 6, 2025GA, IN, MI +1 more• GBC Food Services, LLC

Endurance Boost Capsules (EnShiShiXiangNi) – Undeclared Sildenafil (2025)

Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).

FDAMay 6, 2025Nationwide• EnShiShiXiangNiShangMaoYouXianGongSi

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