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All product recalls affecting Pennsylvania.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Pennsylvania in the distribution area.
This recall involves the Yoto Mini, a portable connected screen-free speaker intended for children ages three to twelve. The Yoto Mini is operated by use of Yoto cards and is designed to play audiobooks, music, radio and podcasts. The speakers are pale gray with orange tactile controls and a pixel display. The model name Yoto Mini, SKU PRPLXX00860, and serial number are located on the base of the product. The recalled Yoto Mini was sold with a charging cable included but no adaptor or charger.
This recall involves HTRC C240 battery chargers sold for charging lithium-ion batteries. The defective chargers are black with two blue screens, numbered 1 and 2, and the model identifier "C240 DUO" printed between the screens. The brand name "HTRC" is printed at the bottom left corner.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine
General Motors LLC (GM) is recalling certain 2025 Chevrolet Equinox EV vehicles. The pedestrian alert sound system may have incorrect software and not produce sound at a sufficient volume. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 141, "Minimum Sound Requirements for Hybrid and Electric Vehicles."
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Product contains undeclared FD&C Yellow 5 and FD&C Yellow 6.
Gillig, LLC (Gillig) is recalling certain 2023 Low Floor diesel-hybrid transit buses. During vehicle operations in full electric vehicle (EV) mode, the odometer will not display accumulated mileage. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 101, "Controls and Displays."
Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account.