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All product recalls affecting Puerto Rico.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Puerto Rico in the distribution area.
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.
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.
Rivian Automotive, LLC. (Rivian) is recalling certain 2024 R1T and R1S vehicles. The dashboard air bag warning label may be missing. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 208, "Occupant Crash Protection."
This recall involves Spin Swivel Chairs. The upholstered swivel chairs have gold-colored stainless steel swivel legs and were sold in ivory, gray, orange, and blue upholstery. The swivel chairs measure approximately 32.5 inches tall, 32 inches deep, and 30.5 inches wide.
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 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.
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.
The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.
Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.
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.
General Motors, LLC (GM) is recalling certain 2024 Cadillac Lyriq, Chevrolet Blazer EV, Chevrolet Silverado EV, GMC Hummer EV SUV, and GMC Sierra EV vehicles. The electric motors in the rear drive units may have insufficiently insulated wires that can contact each other, resulting in a loss of drive power.