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Showing 3521–3540 of 4465 results

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HistoCore PELORIS 3 (Leica Biosystems) – Tubing Leakage Issue (2025)

There is a leakage issue associated with the tubing in the manifold of the instrument.

FDAApr 2, 2025AZ, CA, FL +11 more• Leica Biosystems Melbourne Pty Ltd

Haloperidol Decanoate Injection (Amerisource) – Sterility Risk (2025)

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

Class IIModerate

FDAApr 2, 2025Nationwide• Amerisource Health Services LLC

Entegra Anthem (Entegra) – Diesel Fuel System Issue (2025)

Fire/Burn Risk

Jayco, Inc. (Jayco) is recalling certain 2024-2025 Entegra Anthem, Aspire, and 2025 Reatta XL motorhomes, equipped with Cummins L9 diesel engines. The remote fuel filter hose may separate from the fitting, causing a fuel leak and an engine stall.

High

NHTSAApr 2, 2025Nationwide• ENTEGRA

Biomet 3i Abutment (Preat) – Screw Seat Positioning Problem (2025)

Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the associated implant.

FDAApr 2, 2025Nationwide• Preat Corp

Aquadis 56 Washer Disinfector (Getinge) – Circulation Pump Timing Error (2025)

The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing.

FDAApr 2, 2025Nationwide• Getinge Disinfection Ab Ljungadalsgatan

Brilliance CT Big Bore (Philips) – Gantry Motion Risk (2025)

Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.

FDAApr 1, 2025Nationwide• Philips North America Llc

Gillig Low Floor (Gillig) – Battery Hardware Loose (2025)

Gillig, LLC (Gillig) is recalling certain 2023-2024 Low Floor transit buses. The high voltage batteries may have loose hardware that can fall inside the battery pack and create a short circuit.

NHTSAApr 1, 2025Nationwide• GILLIG

myQA iON (IBA Dosimetry) – Analysis Result Inaccuracy (2025)

Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.

FDAApr 1, 2025Nationwide• IBA Dosimetry GmbH Bahnhofstr. 5 Schwarzenbruck Germany

BMW 430I (BMW) – Starter Assembly Issue (2025)

BMW of North America, LLC (BMW) is recalling certain 2025 330i, 330i xDrive, 530i, 530i xDrive, 4 Series Coupe (430i, 430i xDrive), 4 Series Convertible (430i, 430i xDrive), 4 Series Gran Coupe (430i, 430i xDrive) and X3 30 xDrive vehicles. The electrical connection between the starter-generator and battery may come loose.

NHTSAApr 1, 2025Nationwide• BMW

Bollinger Motors B4 (Bollinger Motors) – Battery Pack Seal Problem (2025)

Bollinger Motors, Inc. (Bollinger Motors) is recalling certain 2025 B4 trucks. The high voltage battery pack may be improperly sealed and allow liquid to enter the battery.

NHTSAApr 1, 2025Nationwide• BOLLINGER MOTORS

California Veggie Fries (Dr. Praeger's) – Undeclared Soy (2025)

Undeclared Allergen

Undeclared Allergen (Soy)

Class IIModerate

FDAApr 1, 2025CA, CO, CT +12 more• Dr. Praeger's Sensible Foods Inc.

Dexmedetomidine HCl (Denver Solutions) – Leaking Syringes (2025)

Lack of Assurance of Sterility: Leaking/damaged syringes.

Class IIModerate

FDAMar 31, 2025Nationwide• Denver Solutions, LLC DBA Leiters Health

Phenylephrine HCl (Denver Solutions) – Leaking Syringes (2025)

Lack of Assurance of Sterility: Leaking/damaged syringes.

Class IIModerate

FDAMar 31, 2025Nationwide• Denver Solutions, LLC DBA Leiters Health

Sodium Chloride Irrigation (B. Braun) – Particulate Matter (2025)

Presence of Particulate Matter

Class IIModerate

FDAMar 31, 2025Nationwide• B. Braun Medical Inc

Ketamine HCl (Denver Solutions) – Leaking Syringes (2025)

Lack of Assurance of Sterility: Leaking/damaged syringes.

Class IIModerate

FDAMar 31, 2025Nationwide• Denver Solutions, LLC DBA Leiters Health

Aries LFP Battery Pack (Aries LFP) – Battery Pack Concern (2025)

Our Next Energy is recalling certain Aries LFP battery packs sold for use in commercial trucks, with part numbers 10108 and 1633. The battery pack may be improperly sealed and allow liquid to enter the battery.

NHTSAMar 31, 2025Nationwide• ARIES LFP

3.0 Liter Disposable Set (Belmont) – Connector Crack Risk (2025)

Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.

FDAMar 31, 2025Nationwide• Belmont Instrument LLC

Glycopyrrolate (Denver Solutions) – Leaking Syringes (2025)

Lack of Assurance of Sterility: Leaking/damaged syringes.

Class IIModerate

FDAMar 31, 2025Nationwide• Denver Solutions, LLC DBA Leiters Health

Halyard Rapides E-Pack (AVID Medical) – Needle Coating Problem (2025)

An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.

FDAMar 31, 2025Nationwide• AVID Medical, Inc.

Hyperthermia Pump Kit (Belmont) – Connector Crack Risk (2025)

Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.

FDAMar 31, 2025Nationwide• Belmont Instrument LLC

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