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All product recalls affecting New York.
Includes nationwide recalls (tagged “Nationwide”) and recalls with New York in the distribution area.
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Ford Motor Company (Ford) is recalling certain 2022-2024 Maverick, 2020-2022 Escape, and 2021-2022 Lincoln Corsair vehicles. The Hybrid Powertrain Control Module (HPCM) software may cause the vehicle to shift into neutral unexpectedly, causing a loss of drive power.
Product contains elevated levels of undeclared sulfites.
Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
This recall involves Arctic Cat model year 2024 Catalyst 600 snowmobiles with model names ZR, Riot, and Mountain, sold in various colors. The model names are printed on the side panels of the snowmobiles. The 10th letter of the VIN will be an "R". The VIN number is stamped on the tunnel section or the decal on the top/rear of the tunnel.
Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party software, such as PACS or other post-processing software, which may lead to inaccurate diagnoses or treatment.
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
This recall involves single-door and double-door ZLINE built-in electric wall ovens with model numbers AWS-30, AWD-30, AWS-30-BS, AWD-30-BS, AWSS-30, and AWDS-30. The recalled ovens were sold in stainless steel and black stainless with a digital control at the top of the unit. The recalled product is approximately 30 inches wide by 24.5 inches deep by 51 inches high for the double wall oven, and 29 inches high for the single wall oven. The ZLINE logo is printed on the bottom face of the door. The serial number and the manufacturing date in YYYYMMDD format are printed on a white label located inside the right side of the oven. The serial numbers range between 207986920110001 and WOAR2112048400, and the manufacturing dates between November 2020 and December 2021 are shown as 20201101 through 20211231.
This recall involves Zegoo-branded 100% cotton children's nightgowns sold in light pink, pink, and blue. The nightgowns are short-sleeved, and have a double-lace layer at the collar with a small ribbon bow. A side-seam label lists the size, "100% Cotton," and "MADE IN CHINA."
This recall involves SIORO-branded 100% cotton, terry cloth children's robes. They are long-sleeved with a hood, two front pockets, and a matching belt. The robes were sold in the following additional colors: Rose Pink, Light Pink, Pure White, Falcon Gray and Green Mist, with Light Blue, Navy, Peacock Blue, Gray Blue and Plum colors in the original recall. Sizes sold include 4-5T, 6-7 Years, and 8-10 Years. On the front of the neck label is a flamingo, "100% Cotton", and "Made in China". On the back of the neck label are washing instructions.
This recall involves plastic toy pinwheels that were given away as a promotional item for free at Cotton On stores. The toy pinwheels are multi-colored and have "KIDS" and "COTTON ON" in white letters on the pinwheels.
This recall involves model years 2022 and 2023 Prowler Pro, Prowler Pro Crew, Tracker 800SX, and Tracker 800SX Crew utility vehicles. They were sold in various colors, including green, gray, red, fossil, and timber. "Prowler" or "Tracker" is stamped on the side of the cargo box. The 10th digit of the vehicle identification number (VIN), which is printed on the operator side of the frame under the cargo box, includes an "N" for model year 2022 and a "P" for model year 2023.