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All product recalls affecting Puerto Rico.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Puerto Rico in the distribution area.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Labeling contains claims that are not consistently present.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Labeling contains claims that are not consistently present.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
McNeilus Truck & Manufacturing, Inc. (McNeilus) is recalling certain 2024-2025 Volterra side loader trucks. The intermediate side reflex reflectors may be missing. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, "Lamps, Reflective Devices, and Associated Equipment."