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Product lacks 510(k) clearance.
Subpotent Drug
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Thor Motor Coach (TMC) is recalling certain 2023 Gemini and Compass motorhomes. Washers were not installed with the roof mounting brackets.
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
MORryde International, Inc. (MORryde) is recalling certain IST22-008 suspensions installed on Grand Design Serenova travel trailers. The axle bearing nut may have been improperly tightened, causing the bearings to overheat.
Columbus Trading-Partners USA, Inc. (CTP) is recalling certain Cybex Aton G, Aton G SensorSafe, Aton G Swivel, Aton G Swivel SensorSafe, Eos and Aton G Swivel Travel System, Eos and Aton G Travel System, Libelle and Aton G Travel System, and Beezy and Aton G Travel System child seats. The harness hip anchorage retention hooks may bend, causing the anchor pin to loosen, and the harness strap to detach.
Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.