FDA (Devices) recall action 96309

Oridion Medical 1987 Ltd. recalled 10 products on 2025-03-26

The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.

Products: 10
Announced: 2025-03-26
Critical: 0
Units: 14,700,798

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–10 of 10

HighFDA (Devices)··2025-03-26
CO2 Sampling Line Adapter May Be Difficult to Disconnect; Risk of Respiratory Failure
Microstream CO2 sampling line and airway adapter may be difficult or impossible to disconnect during procedures, potentially causing treatment delays and respiratory complications including hypoxia.
Product
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;
Category
Distribution
51 states
HighFDA (Devices)··2025-03-26
Microstream CO2 sampling lines recalled for difficult adapter disconnection
Microstream CO2 sampling lines may be difficult to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended tube removal.
Product
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 Microstream Technology H, Length 7 (2.0 m), 006324COV; CapnoLine
Category
Distribution
51 states
HighFDA (Devices)··2025-03-26
Microstream neonatal CO2 filter lines difficult to disconnect from breathing tubes
Microstream Advance neonatal-infant CO2 sampling lines may be difficult to disconnect from endotracheal tubes, potentially delaying critical procedures. This could cause unintended extubation and respiratory complications in infants.
Product
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 Extended Duration, MVIIH; Microstream Advance Neonatal-Infan
Category
Distribution
51 states
HighFDA (Devices)··2025-03-26
Microstream CO2 Sampling Lines May Be Difficult to Disconnect From Breathing Tubes
Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially causing treatment delays and unintended extubation with risk of serious complications.
Product
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 Line and Airway Adapter for Humid Environments, 007737; MICR
Category
Distribution
51 states
HighFDA (Devices)··2025-03-26
Microstream CO2 Intubated Filter Lines Difficult to Disconnect
Microstream CO2 filter lines used with intubated patients may be difficult or impossible to disconnect from the endotracheal tube, potentially delaying treatment or causing unintended extubation.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediatric Intubated, PT00134333 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, QMVAI; Microstre
Category
Distribution
51 states
HighFDA (Devices)··2025-03-26
Microstream CO2 Sampling Line Disconnection Failure Poses Respiratory Risk
Microstream CO2 sampling adapters may become difficult or impossible to disconnect from endotracheal tubes, potentially delaying critical procedures and causing respiratory complications.
Product
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/6.5ft Short-term use: Procedural/Emergency, MVAI; Microst
Category
Distribution
51 states
HighFDA (Devices)··2025-03-26
Microstream CO2 Sampling Line May Not Disconnect From Intubation Tube
Microstream intubated CO2 sampling lines may be difficult or impossible to disconnect from endotracheal tubes. This could delay necessary procedures and cause unintended extubation, potentially leading to respiratory failure.
Product
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/6.5ft Short-term use: Procedural/Emergency, MLAI
Category
Distribution
51 states
HighFDA (Devices)··2025-03-26
CO2 Sampling Lines May Fail to Disconnect During Neonatal Care
Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended extubation. The defect affects neonatal and pediatric patients worldwide.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 006324; MICROSTREAM
Category
Distribution
51 states
HighFDA (Devices)··2025-03-26
Microstream Neonatal-Infant CO2 Filter Line May Be Difficult to Disconnect
Microstream Neonatal-Infant Intubated CO2 Filter Lines may become difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially delaying treatment and causing unintended extubation.
Product
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 Extended Duration, QMVIIH
Category
Distribution
51 states
HighFDA (Devices)··2025-03-26
CO2 Sampling and Airway Adapter Devices May Be Difficult to Disconnect
Oridion Medical's CO2 sampling and airway adapter devices may be difficult to disconnect from endotracheal tubes, potentially causing treatment delays and serious respiratory complications in neonatal, infant, and pediatric patients.
Product
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 Sampling Line X25, 010991
Category
Distribution
51 states