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Showing 9341–9360 of 35916 results

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Achieva 1.5T Initial System (Philips) – fire potential (2023)

Potential component failure in the Gradient Coil could product smoke and/or fire.

FDAOct 23, 2023Nationwide• Philips North America Llc

Sage PrimaFit Urine Management (Sage) – undeclared latex (2023)

A small percentage of devices in three lots of product may contain a tape with a natural rubber latex adhesive which is not declared on the label

FDAOct 23, 2023Nationwide• Sage Products Inc 3909 3 Oaks Rd Cary IL 60013-1804

Achieva 1.5T Conversion (Philips) – fire potential (2023)

Fire/Burn Risk

Potential component failure in the Gradient Coil could product smoke and/or fire.

High

FDAOct 23, 2023Nationwide• Philips North America Llc

Ranolazine Tablets 500mg (Glenmark) – failed dissolution (2023)

Failed Dissolution Specifications: Out of specification for dissolution.

Class IIModerate

FDAOct 23, 2023Nationwide• Glenmark Pharmaceuticals Inc., USA

Intera 1.5T (Philips) – fire potential (2023)

Potential component failure in the Gradient Coil could product smoke and/or fire.

FDAOct 23, 2023Nationwide• Philips North America Llc

Coachmen Cross Trail (Coachmen) – refrigerator risk (2023)

Forest River, Inc. (Forest River) is recalling certain 2023-2024 Coachmen Cross Trail Class C motorhomes. The 12-volt refrigerator may dislodge and fall from its cabinet.

NHTSAOct 20, 2023Nationwide• COACHMEN

Coachmen Concord (Coachmen) – suspension system risk (2023)

Forest River, Inc. (Forest River) is recalling certain 2023-2024 Coachmen Concord Class C motorhomes. Installation of the air ride suspension system resulted in an incorrect pinion to driveline angle.

NHTSAOct 20, 2023Nationwide• COACHMEN

Lion LionC (Lion) – brake system risk (2023)

Lion Electric Company (Lion Electric) is recalling certain 2024-2025 LionC School Buses. The anti-lock brake system (ABS) pneumatic valve connections and rear wheel speed sensors may be installed incorrectly.

NHTSAOct 20, 2023Nationwide• LION

BMW X5 (BMW) – engine cooling issue (2023)

BMW of North America, LLC (BMW) is recalling certain 2010-2012 1 Series Coupe, 1 Series Convertible, 3 Series Sedan, 3 Series Convertible, 2010-2011 3 Series Sportswagon, 3 Series Coupe, 5 Series Sedan, X3 xDrive 28i, X3 xDrive 30i, X5 xDrive30i, and Z4 sDrive30i vehicles. The aluminum bolts that secure the housing for the variable camshaft timing adjustment (VANOS) unit can loosen over time and possibly break.

NHTSAOct 20, 2023Nationwide• BMW

New Flyer XE40 (New Flyer) – labeling issue (2023)

New Flyer of America, Inc. (New Flyer) is recalling certain 2021-2023 XD35, 2022-2023 XD40, XD60, XN35, XN60, 2022 XDE35, and 2021-2022 XE40 transit buses. The Gross Axle Weight Rating (GAWR) and Gross Vehicle Weight Rating (GVWR) listed on the certification labels are incorrect, which can allow the vehicle to be overloaded. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 120, "Wheels and Rims - Other than Passenger Cars."

NHTSAOct 20, 2023Nationwide• NEW FLYER

Equate Hand Sanitizer (Omega & Delta) – Potency Issue (2023)

Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.

Class IIModerate

FDAOct 20, 2023IN, PR• Omega & Delta Co., Inc.

Oxaydo Tablets (Zyla Life Sciences) – Sub-potent Drug (2023)

Sub-potent Drug: Lower potency than labeled.

FDAOct 20, 2023Nationwide• Zyla Life Sciences US Inc.

DOP Hand Sanitizer Original (Omega & Delta) – Potency Problem (2023)

Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.

Class IIModerate

FDAOct 20, 2023IN, PR• Omega & Delta Co., Inc.

Kuka Flex Forte Caplets (Botanical Be) – Undeclared Ingredient (2023)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.

FDAOct 20, 2023Nationwide• Botanical Be

Reumo Flex Caplets (Botanical Be) – undeclared ingredient (2023)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.

FDAOct 20, 2023Nationwide• Botanical Be

Artri King Reforzado Tablets (Botanical Be) – Undeclared Ingredient (2023)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.

FDAOct 20, 2023Nationwide• Botanical Be

Deferasirox Oral Suspension (Glenmark) – failed dissolution (2023)

Failed Dissolution Specifications

Class IIModerate

FDAOct 20, 2023Nationwide• Glenmark Pharmaceuticals Inc., USA

DOP Hand Sanitizer (Omega & Delta) – Potency Concern (2023)

Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.

Class IIModerate

FDAOct 20, 2023IN, PR• Omega & Delta Co., Inc.

Jaguar I-PACE (Jaguar) – battery system issue (2023)

Jaguar Land Rover North America, LLC (Jaguar) is recalling certain 2019-2023 I-PACE vehicles previously repaired under recall 23V-369. The previous repair may not have been completed correctly, and still allow the high-voltage battery to overheat.

NHTSAOct 19, 2023Nationwide• JAGUAR

Altec Digger Derrick (Altec) – turntable failure (2023)

Altec Industries, Inc. (Altec) is recalling certain 2023 DC and DM Digger Derricks. The turntable rotation gearbox may fail at high loads due to a defect in the brake flange casing.

NHTSAOct 19, 2023Nationwide• ALTEC

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