Microstream Instructions for Use and Part Number used with — Class II medical device recall Z-1379-2025
Ongoing recall by Oridion Medical 1987 Ltd., reported 2025-03-26, distributed nationwide. Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filt
| Recall number | Z-1379-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Oridion Medical 1987 Ltd., Jerusalem, N/A, Israel |
| Recall initiated | 2025-02-17 |
| Classified | 2025-03-17 |
| Reported by FDA | 2025-03-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IE, IL, IN, IS, IT, JO, JP, KE, KR, KW, LB, LT, LU, LV, MA, MT, MX, MY, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TR, UA, UY, ZA |
| Quantity | 7,076 |
| UPC / GTIN / UDI-DI | 10884521554092, 10884521762152, 20884521552033, 20884521762159 |
| Lot numbers | 01158, C220975945, PT00156356 |
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1379-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.