Philips North America Recalls

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

FDAJun 30, 2025Nationwide• Philips North America

Omeprazole Capsules (Dr. Reddy's) – Foreign Tablets (2025)

Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.

Class IIModerate

FDAJun 30, 2025Nationwide• Dr. Reddy's Laboratories, Inc.

Ingenia 1.5T (Philips) – Gradient Coil Failure (2025)

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

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High

FDAJun 30, 2025Nationwide• Philips North America

Achieva XR (Philips) – Gradient Coil Failure (2025)

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

FDAJun 30, 2025Nationwide• Philips North America

Fresh Sliced Mushrooms (Aunt Mid's) – Listeria Risk (2025)

Listeria

Potential to be contaminated with Listeria monocytogenes

FDAJun 29, 2025MI• Wiet Peeters Farm Products Limited

Thick Slice Mushrooms (Peeters) – Listeria Risk (2025)

Listeria

Potential to be contaminated with Listeria monocytogenes

FDAJun 29, 2025MI• Wiet Peeters Farm Products Limited

Cremini Sliced Mushrooms (Peeters) – Listeria Risk (2025)

Listeria

Potential to be contaminated with Listeria monocytogenes

FDAJun 29, 2025MI• Wiet Peeters Farm Products Limited

Sprouted Moong (Deep) – Salmonella Contamination (2025)

Salmonella

Product tested positive Salmonella .

FDAJun 28, 2025CA, FL, IL +2 more• CHETAK NEW YORK LLC

Sprouted Mat (Deep) – Salmonella Contamination (2025)

Salmonella

Product tested positive Salmonella .

FDAJun 28, 2025CA, FL, IL +2 more• CHETAK NEW YORK LLC

Sprinter Cart Infusion Pole (Maquet) – Labeling Requirement (2025)

Device does not comply with the labeling requirements of international standard IEC 60601-1.

Low

FDAJun 27, 2025Nationwide• Maquet Cardiopulmonary Gmbh Kehler Str. 31 Rastatt Germany

Cascadia Fifth Gen (FREIGHTLINER) – Fuel Line Risk (2025)

Daimler Trucks North America LLC (DTNA) is recalling certain 2026 Freightliner Cascadia Fifth Gen vehicles. The compressed natural gas fuel line was routed incorrectly, allowing it to chafe and damage wiring harnesses and brake lines.

NHTSAJun 27, 2025Nationwide• FREIGHTLINER

Injection Needle (Spiggle & Theis) – Cytotoxicity Risk (2025)

Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.

FDAJun 27, 2025Nationwide• Spiggle & Theis Mt Gmbh Lagerstr. 11 Dieburg Germany

Great Dane Champion (GREAT DANE) – Door Bolt Problem (2025)

Great Dane Trailers (Great Dane) is recalling certain 2026 Champion dry van trailers. The roll-up door operator bolts may not have been properly tightened and increasing the force required to open or close the door.

NHTSAJun 26, 2025Nationwide• GREAT DANE

UIBC Assay (Beckman Coulter) – Hemoglobin Interference (2025)

Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant interference (i.e., less than 10%) up to 200 mg/dL hemoglobin as indicated in their instructions for use. Initial internal testing confirmed that samples with low UIBC levels failed the claimed hemolysis interference specifications with reported biases up to -43.6 % UIBC when hemolyzed serum samples contained 200 mg/dL hemoglobin.

FDAJun 26, 2025AL, AK, AR +8 more• Beckman Coulter Inc.

Breathing Circuit Set (Hamilton Medical) – Tubing Crack (2025)

Laceration Risk

Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete rebreathing of exhaled gases, which could lead to acute hypercapnia, respiratory acidosis, and if unrecognized organ dysfunction.

FDAJun 26, 2025Nationwide• Hamilton Medical AG Parc Industrial Vial 10 Domat/Ems Switzerland

RAPIDPoint 500 Wash Cartridge (Siemens) – Manufacturing Error (2025)

Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride, pCO2, Glucose and Lactate analytes and their derivatives. Four complaints were filed related to this event that led to Siemens Healthcare Diagnostics identifying an error in the manufacturing process and initiated corrective actions. Use of the affected device may result in errors during QC which could lead to a delay in patient treatment. If bias generated from this issue is not caught during QC erroneous results may cause temporary or medically reversible adverse health consequences to patients.

FDAJun 26, 2025Nationwide• Siemens Healthcare Diagnostics Inc

Bicycle Helmets (Bell Sports) – head injury risk (2025)

This recall involves Bell Sports' Axle, Cadence, Rev and Frenzy children's bicycle helmets with model numbers B0605Y, B0605C or B0494Y, and Cadence and Passage adult helmets with model number B0605Y. The helmets were sold in the following colors or color combinations: blue, green, purple, red, pink, black/blue, green/black, pink/green, pink/purple, pink/white, purple/white, red/black, pink/mint or multi-color; and have various designs, including checkers, lines, polka dots, rainbows and swirls. The model name, the model number, and the manufacture date in MM/YY or M/YY format can be found on a sticker inside the helmet. Model Number Model Name Color(s) Manufacture Date B0494Y Axle Pink/Purple and Pixels Green 9/24 B0605C Cadence Rainbow Road 10/24 Red 9/24 Pink/White Checkers 9/24 and 10/24 Black/Blue 10/24 Blue/Black and Purple/White 8/24, 9/24 and 10/24 Rev Red/Black Swirl 8/24 and 9/24 B0605Y Cadence Black/Red 9/24 Pink/Mint Black/Blue Purple Pink Polka Green/Black Frenzy Blue/Black and Pink Scuba Passage Blue Comet

CPSCJun 26, 2025Nationwide• Bell Sports Inc., of Irvine, California

LiPRO Battery Packs (DR Power) – fire hazard (2025)

This recall involves 62-volt 5.0 Ah LiPRO rechargeable lithium-ion battery packs for use with DR Power brand battery-powered products, such as lawnmowers, trimmers and snow throwers. The products include stand-alone battery packs with model number 414240, and removeable battery packs included with DR Power outdoor yard equipment items with model numbers 524340, SB11022XEN, T4X3026XEN, T4X3062XENR, CE75021XEN0 and CE77021XEN0. Information containing the model number for the battery pack ("41424") is located on the battery pack's label. The LiPRO and DR Power logo are on the front and side panels of the battery pack. Note: Do not throw this recalled lithium-ion battery or device in the trash, the general recycling stream (e.g., street-level or curbside recycling bins), or used battery recycling boxes found at various retail and home improvement stores. Recalled lithium-ion batteries must be disposed of differently than other batteries, because they present a greater risk of fire. Your municipal household hazardous waste (HHW) collection center may accept this recalled lithium-ion battery or device for disposal. Before taking your battery or device to a HHW collection center, contact that office ahead of time and ask whether it accepts recalled lithium-ion batteries. If it does not, contact your municipality for further guidance.

CPSCJun 26, 2025Nationwide• Ningbo New Team Import & Export Co. Ltd. ("Lera"), of China

Temsa TS30 (TEMSA) – Exit Lock Mechanism (2025)

Temsa is recalling certain 2022-2025 TS30, 2023-2024 TS45, 2024 TS35, and 2025 TS45E vehicles. The lock mechanism may have been installed incorrectly, causing the roof hatch release handle to break.

NHTSAJun 26, 2025Nationwide• TEMSA

DxI 800 Immunoassay Analyzer (Beckman Coulter) – Software Issue (2025)

Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.