Microstream Instructions for Use and Part Number used with — Class II medical device recall Z-1385-2025
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-1385-2025 |
|---|---|
| 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 | 704,423 |
| UPC / GTIN / UDI-DI | 10884521761988, 10884521761995, 10884521762015, 10884521762275, 20884521761985, 20884521762012 |
| Lot numbers | C210525057, C210736860, C211070952, C211070955, C211101243, C211101307, C211105839, C211213507, C211213581, C220103340, C220108515, C220213101, C220213102, C220213149, C220317965, C220319423, C220319472, C220540880, C220646813, C220646817, C220646858, C220650235, C220858356, C220861928, C220863127, C220865467, C220866691, C220974773, C220974781, C220974783, C220978900, C221081920, C221088533, C221191770, C221193708, C221295623, C230206266, C230211851, C230313137, C230314185 and 51 more |
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-Infant Intubated CO2 Filter Line 2m/6.5ft High Humidity, MVIIHH; Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 4m/13ft Extended Duration, MVIIHL; Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, ZMVIIH
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-1385-2025. 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.