Drug & Device Safety Atlas

FDA recall record · openFDA

Oridion Medical 1987 Ltd.

10 FDA recalls on record (2025) — 10 device. 10 still ongoing.

0
Class I (most serious)
10
Class II
0
Class III
10
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) L 10

Recalls

Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediat Class II 2025-02-17 Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Class II 2025-02-17 Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Se Class II 2025-02-17 Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampli Class II 2025-02-17 Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Class II 2025-02-17 Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - Class II 2025-02-17 Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Ad Class II 2025-02-17 Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intub Class II 2025-02-17 Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediat Class II 2025-02-17 Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Class II 2025-02-17

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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