Microstream Instructions for Use and Part Number used with — Class II medical device recall Z-1384-2025
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-1384-2025 |
|---|---|
| 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 | 8,435,772 |
| UPC / GTIN / UDI-DI | 10884521761889, 10884521761896, 10884521761902, 10884521761919, 10884521761926, 10884521761933, 10884521762008, 10884521783980, 10884521783997, 20884521761886, 20884521761893, 20884521761909, 20884521761916, 20884521762258, 20884521762265, 20884521771762 |
| Lot numbers | 20G0601JZ, 20G0602JZ, 20G0603JZ, 21A0812JZ, 21A0813JZ, 21A0814JZ, 21A0815JZ, 21A0816JZ, 21A0817JZ, 21A0818JZ, 21A0819JZ, 21A0820JZ, 21A0821JZ, 21A0822JZ, 21A0823JZ, 21B0737JZ, 21C0184JZ, 21C0185JZ, 21C0186JZ, 21C0920JZ, 21C0921JZ, 21C0922JZ, 21G0025JZ, 21G0026JZ, 21G0027JZ, 21G0031JZ, 21G0396JZ, 21G0397JZ, 21G0398JZ, 21G0529JZ, 21G0698JZ, 21H0057JZ, 21H0058JZ, 21H0059JZ, 21H0060JZ, 21H0061JZ, 21H0978JZ, 21H0979JZ, 21H0980JZ, 21H0981JZ and 460 more |
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; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, MVAI100U; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Extended Duration, MVAIH; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Extended Duration, MVAIH100U; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft High Humidity, MVAIHH; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 4m/13ft Extended Duration, MVAIHL; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 4m/13ft Short-term use: Procedural/Emergency, MVAIL; Microstream Advance Air Military Sample Kit CO2 Oral-Nasal Filter Line with O2 Tubing (MVAO) and Adult-Pediatric Intubated Filter Line, High Humidity (MVAIHH) 2m/6.5ft, MVAMSK; Microstream Advance Adult Sample Kit CO2 Intubated Filter Line (MVAI) and CO2 Oral-Nasal Filter Line with O2 Connector (MVA) 2m/6.5ft, MVASK; Microstream Advance Adult-Pediatric IntubatedCO2 Filter Line 2m/6.5ft Extended Duration, ZMVAIH; Microstream Advance Adult-Pediatric IntubatedCO2 Filter Line 2m/6.5ft High Humidity, ZMVAIHH; Microstream Advance Adult-Pediatric IntubatedCO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, ZMVAI;
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-1384-2025. 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.