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All product recalls affecting New Jersey.
Includes nationwide recalls (tagged “Nationwide”) and recalls with New Jersey in the distribution area.
Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's internal investigation determined that 0.14% of the LIAISON Q.S.E.T. Device Plus in the lots identified have loose clear caps, which may allow buffer to leak from the tube. A stool sample prepared with less than the correct amount of buffer may result an incorrectly high patient result.
Hyundai Motor America (Hyundai) is recalling certain 2024 Santa Fe and Santa Fe Hybrid vehicles. The overhead console rear sunshade switch knob may not be fully recessed, which can result in unintentional closing of the sunshade. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 118, "Power-Operated Window, Partition and Roof Panel Systems."
This recall involves Kyte Baby Slumber Suits, which are one-piece sleep garments for babies. "Kyte Baby", the size, "Made in China" and care instructions are printed on the inside neck label. The recalled Slumber Suits were sold in sizes Medium (M), Large (L) and Extra Large (XL), and the colors Midnight, Taro, Slate, Sage, Blush, Cloud, Alpine Village, Crepe, Racoon, Jurassic, Eucalyptus, Blue Heron, Cloud Poppies, Haze, Midnight Poppies and Coastline.
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Due to finished goods incorrectly packaged and labeled.
PJ Trailers is recalling certain 2024-2025 LD trailers. The air ride suspension brake axles may be installed incorrectly, resulting in reduced braking ability.
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Sumitomo Rubber USA, LLC (Sumitomo) is recalling certain Falken WildPeak AT4W size 275/60R20 115T tires. The tires may have been produced using the incorrect cord material for one of the plies. The sidewall label incorrectly identifies the generic name of the cord material. As such, the affected tires do not meet the labeling requirements of Federal Motor Vehicle Safety Standard number 139, New pneumatic radial tires for light vehicles.
Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.
BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may result in falsely resistant result for ampicillin susceptibility
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
cGMP Deviations: Out of specification results for micro in hand soap products.
cGMP Deviations: Out of specification results for micro in hand soap products.
cGMP Deviations: Out of specification results for micro in hand soap products.
Winnebago Industries, Inc. (Winnebago) is recalling certain 2014-2018 Sightseer, Itasca Sunova, 2016-2025 Forza, Vista, and Itasca/Winnebago Sunstar, 2015-2025 Adventurer, 2015-2024 Commercial Vehicle, 2015-2028 Itasca Suncruiser, and 2016-2017 Itasca Solei recreational vehicles. The hood bracket adhesive may have been incorrectly applied which can allow the bracket to detach.