Jerusalem, Israel
Oridion Medical 1987 Ltd. recalls
2 recalls recorded since 2018, most recently on 17 February 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 17 February 2025
- Reason
- 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.
- Distribution
- Worldwide - US Nationwide distribution including in the states of TX, OH, FL, CO, IL, CA, MD, PA, VA, WI, IN, MI, NY, GA, OR, SC, NC, PR, AZ, KY, AR, TN, MO, DE, MA, MS, UT, DC, NE, IA, WV, NJ, KS, LA, WA, HI, MN, AL, ME, RI, OK, MT, ID, CT, NH, AK, NV, SD, WY, ND, NM and the countries of Algeria, A
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1378-2025, Z-1385-2025, Z-1377-2025, Z-1379-2025, Z-1384-2025, Z-1380-2025, Z-1383-2025, Z-1382-2025, Z-1381-2025, Z-1376-2025
- Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 - CapnoLine Neonatal-Infant Intubated Filter Line with Microstre
- Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Infant, PT00156250 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Ext
- Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 - MICROSTREAM FilterLine H Set Long Adult-Pediatric CO2 Sampling Lin
- Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling Line, 01158 - Microstream Luer Adult-Pediatric Airway Adapter, 010989; Omnistream CO2 Samp
- Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT00156254 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/
- Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 012495;
- Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - Microstream Luer Adult-Pediatric Intubated CO2 Sampling Line 2m/6.5f
- Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extend
- and 2 more product lines
Terminated Class II Medical devices
- Recall started
- 31 July 2018
- Terminated
- 20 September 2022
- Reason
- 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.
- Distribution
- The products were distributed US nationwide and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Bahrain, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israe
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0045-2019, Z-0043-2019, Z-0026-2019, Z-0034-2019, Z-0040-2019, Z-0044-2019, Z-0051-2019, Z-0046-2019, Z-0039-2019, Z-0036-2019, Z-0041-2019, Z-0028-2019 and 25 more
- Capnostream20 M ADULT ICU (CPM), CS08654RA
- CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03
- CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
- Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657
- CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658
- Capnostream20 (INTL) M, CS08654
- Capnostream20 (INTL) N REFURBISHED, CS78652
- Capnostream20 M NICU (CPM), CS08654RN
- and 29 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.