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Oridion Medical 1987 Recalls
47 recalls on record · October 10, 2018 to March 26, 2025 · Medical Devices
Recalls by year
18
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 26, 2025Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated
Hazard: 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.
March 26, 2025Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated
Hazard: 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.
March 26, 2025Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Ad
Hazard: 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.
March 26, 2025Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intub
Hazard: 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.
March 26, 2025Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediat
Hazard: 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.
March 26, 2025Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 -
Hazard: 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.
March 26, 2025Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampli
Hazard: 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.
March 26, 2025Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediat
Hazard: 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.
March 26, 2025Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Se
Hazard: 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.
March 26, 2025Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H
Hazard: 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.
October 10, 2018Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS051COV-03
Hazard: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
October 10, 2018Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV
Hazard: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
October 10, 2018Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls Capnostream20 (INTL) M W/PRINTER REFURBISHED, CS78660
Hazard: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
October 10, 2018Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls Capnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658
Hazard: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
October 10, 2018Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls Capnostream20 (INTL) M REFURBISHED, CS78654
Hazard: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
October 10, 2018Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls Capnostream20 (INTL) N REFURBISHED, CS78652
Hazard: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
October 10, 2018Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls Capnostream20 N CYVITAL, CS08799
Hazard: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
October 10, 2018Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls Capnostream20 N W/PRINTER CYVITAL, CS08798
Hazard: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
October 10, 2018Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls Capnostream20 M W/PRINTER CYVITAL, CS08796
Hazard: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
October 10, 2018Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls Capnostream20 (INTL) M W/PRINTER, CS08660
Hazard: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
October 10, 2018Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls Capnostream20 M NICU (CPM), CS08654RN
Hazard: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
October 10, 2018Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls Capnostream20 M ADULT ICU (CPM), CS08654RA
Hazard: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
October 10, 2018Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls Capnostream20 (INTL) M, CS08654
Hazard: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
October 10, 2018Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03
Hazard: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
October 10, 2018Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-02
Hazard: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
October 10, 2018Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls CAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01
Hazard: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
October 10, 2018Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658
Hazard: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
October 10, 2018Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-03
Hazard: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
October 10, 2018Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-02
Hazard: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
October 10, 2018Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls CAPNOSTREAM 20P (INTL) N, Part Number CS08652-01
Hazard: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.