The Magazine for Sleep Professionals
Thursday, April 30, 2026
The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines that may contain a plastic contaminated with a non-compatible material. If that plastic is in the […]
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Puritan Bennett 980 Series Ventilator Model Numbers: See Recall Database Entries Distribution Dates: February 23, 2017 to April 4, 2020 […]
Royal Philips today announced an update in connection with the June 14, 2021 recall notification* for specific Philips sleep and respiratory care devices that was issued to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices. More than half of the affected devices […]
Following the company update on April 26, 2021, Royal Philips has provided an update on the recall notification* for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component […]
Teleflex Incorporated has announced a worldwide voluntary recall of the COMFORT FLO® Humidification System. The recalled products provide a continuous flow of heated and humidified gas to COMFORT FLO® patients in professional health care environments. The products involved in the recall are as follows: Product Name Product Code Lot Numbers COMFORT FLO […]
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death Recalled Product Airway Kit containing Sheridan® Endotracheal Tubes Model numbers: Kit TC7855 Distribution Dates: November 28, 2018 to June 5, 2019 Devices Recalled in […]
Teleflex Incorporated has announced a worldwide recall of certain lots of Hudson RCI® Sheridan® Endotracheal Tubes. The recalled products are designed for oral or nasal intubation and are indicated for airway management. The products involved in this recall are as follows: The U.S. Food and Drug Administration (FDA) has classified […]
On September 5, 2017, Smiths Medical ASD issued a voluntary recall of 71 lots of Sterile Water and Saline for Inhalation USP Products (described in further detail below) that either lacked sufficient documentation to assure sterility or may have been susceptible to leaking. Sterile Water for Inhalation USP (350 mLand 550 mL Humidifier with […]
