Microstream Instructions for Use and Part Number used with — Class II medical device recall Z-1377-2025
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-1377-2025 |
|---|---|
| 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 | 5,125,183 |
| UPC / GTIN / UDI-DI | 10884521184770, 10884521551985, 10884521551992, 10884521552029, 10884521552296, 10884521552340, 10884521554023, 10884521554085, 20884521551784, 20884521551982, 20884521551999, 30884521551989, 30884521551996 |
| Lot numbers | 19J0521JZ, 19J0743JZ, 19J0744JZ, 19J0745JZ, 19J0746JZ, 19J0747JZ, 19J0748JZ, 19J0750JZ, 19J0751JZ, 19J0752JZ, 19J0753JZ, 19K0298JZ, 19K0487JZ, 19K0488JZ, 19K0489JZ, 19K0490JZ, 19K0491JZ, 19K0492JZ, 19K0493JZ, 19K0494JZ, 19K0495JZ, 19K0496JZ, 19K0497JZ, 19K0498JZ, 19K0499JZ, 19K0500JZ, 19K0501JZ, 19K0502JZ, 19K0503JZ, 19K0504JZ, 19K0505JZ, 19K0506JZ, 19K0507JZ, 19K0508JZ, 19K0836JZ, 19K0837JZ, 19L0439JZ, 20A0041JZ, 20A0042JZ, 20A0043JZ and 460 more |
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; MICROSTREAM FilterLine Set Long Adult-Pediatric CO2 Sampling Line and Airway Adapter, 007768; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 010579; MICROSTREAM FilterLine H Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 010580; MICROSTREAM VitaLine H Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for High Ambient Humidity X25, 010787; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 015016; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 015021; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, XS04620; MICROSTREAM FilterLine H Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, XS04624.
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-1377-2025. 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.