DreamStation devices may deliver incorrect therapy due to programming errors. Continued use could cause ineffective treatment or harm.
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Apollo Care LLC. Columbia, MO. 483 issued 03/27/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 03/27/2025
Short Title (70 char) Apollo Care LLC. Columbia, MO. 483 issued 03/27/2025
FEI Number 3013927023
Firm Name Apollo Care LLC
Record Type 483
State MO
Establishment Type Outsourcing FacilityReal-World Evidence Submissions to the Center for Biologics Evaluation and Research & the Center for Drug Evaluation and Research
As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), FDA committed to reporting aggregate and anonymized information on submissions to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).Safety Labeling Change Orders
Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(o)(4)) authorizes FDA to require application holders for certain drugs to make labeling changes based on new safety information. Learn more.CelestaPro – 718613 – 11/03/2025
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This communication is part of the Communications Pilot to Enhance the Medical Device Recall ProgramWestern United Fish Company Recalls Kirkland Signature Brand Ahi Tuna Wasabi Poke Because of Possible Health Risk
September 20, 2025, Western United Fish Company dba Annasea Foods Group of Kent, WA is recalling 3,314.7 lbs. of Kirkland Signature brand Ahi Tuna Wasabi Poke, Costco Item Number of 17193, with the Sell By Date of 9/22/2025, because the green onions used in the product have the potential to be cont