Class II FDA device recall · Z-1384-2025

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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;

Why it was recalled

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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

Part Number and Revision - REF/UDI-DI(Lot): PT00156254 Rev A -     MVAI/20884521761886(C220756034, C221087559, C221192968, C230316355, C230519976, C230837238, C240522589, C240628663, C240729559, D191172616, D201158974, D210312139, D210622030, D210946062, D211154042), 10884521761889(C201200384, C210848192, C210961521, C211092998, C220210315, C220430764, C220538972, C220756034, C220974765, C221087559, C221192968, C230208561, C230314111, C230316355, C230519976, C230523453, C230837238, C231158548, C231158549, C231263415, C240100219, C240522589, C240628663, C240729559, D191172616, D201158974, D201262172, D201262870, D210312139, D210622030, D210946062, D211154042, D220104966, 20G0601JZ, 21A0820JZ, 21A0820JZ, 21A0821JZ, 21A0821JZ, 21A0822JZ, 21C0922JZ, 21G0025JZ, 21G0026JZ, 21G0027JZ, 21G0031JZ, 21G0396JZ, 21G0397JZ, 21G0398JZ, 21H0057JZ, 21H0058JZ, 21H0059JZ, 21H0060JZ, 21H0061JZ, 21H0978JZ, 21H0979JZ, 21H0980JZ, 21H0981JZ, 21H0982JZ, 21I0497JZ, 21I0639JZ, 21I0640JZ, 21J0125JZ, 21J0126JZ, 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24E0525JZ, 24E0526JZ, 24E1481JZ, 24E1482JZ, 24E1483JZ, 24E1484JZ, 24E1485JZ, 24E1486JZ, 24E1487JZ, 24E1488JZ, 24G0510JZ, 24G0511JZ, 24G0512JZ, 24G0513JZ, 24G0514JZ, 24G0515JZ, 24G0516JZ, 24G0517JZ, 24G0518JZ, 24G0519JZ, 24G0520JZ, 24G1251JZ, 24G1252JZ, 24H1079JZ, 24H1080JZ, 24H1081JZ, 24H1083JZ, 24H1084JZ, 24H1085JZ, 24H1086JZ, 24H1087JZ, 24H1088JZ, 24H1089JZ, 24H1090JZ, 24I1056JZ, 24I1057JZ, 24I1058JZ, 24I1059JZ, 24I1060JZ, 24I1061JZ, 24I1062JZ, 24I1063JZ, 24I1064JZ, 24I1065JZ, 24I1076JZ, 24I1077JZ, 24I1078JZ, 24I1079JZ, 24I1080JZ, 24I1081JZ, 24I1082JZ, 24J1144JZ, 24J1145JZ, 24K0906JZ, 24K0907JZ, 24K0908JZ, 24K0909JZ, 24K0910JZ, 24K0911JZ, 24K0912JZ, 24K0913JZ, 24K0914JZ, 24K0915JZ, 24K0916JZ, 24L0928JZ, 24L0929JZ, 24L0930JZ, 24L0931JZ, 24L0932JZ, 24L0933JZ, 24L0934JZ, 24L0935JZ, 24L0936JZ, 24L0937JZ, 24L0938JZ, 25A0989JZ, 25A0990JZ, 25A0991JZ, 25A0992JZ, 25A0993JZ, 25A0994JZ), 20884521761916(21A0815JZ, 21J1171JZ, 21J1172JZ, 22B1184JZ, 22B1186JZ, 22D0252JZ, 22D0253JZ, 22D0254JZ, 22D0319JZ, 22D0321JZ, 22D0322JZ, 22D0323JZ, 22D0324JZ, 22D0325JZ, 22E1463JZ, 22E1465JZ, 22E1466JZ, 22E1474JZ, 22G0075JZ, 22G0077JZ, 22G0079JZ, 22G0081JZ, 22G0082JZ, 22H0170JZ, 22H0176JZ, 22H0179JZ, 22H0655JZ, 22J0861JZ, 22K0843JZ, 22K0851JZ, 23A0716JZ, 23A0719JZ, 23A0722JZ, 23B1234JZ, 23D0146JZ, 23F0266JZ, 23K0514JZ, 24E1481JZ, 24E1484JZ, 24J1144JZ);  MVAIH100U/10884521761926(C210415654, C220974779, C220975952, C221085124, C230211848, C230522202, C230733067, C231159731, C240104050, C240206308, C240414492, D191282624, D201158948, D201262132, D201262846, D210205987, D210517010, D210725654, 21A0816JZ, 21A0817JZ, 21G0698JZ, 21K0566JZ, 21K0567JZ, 21K0568JZ, 22A0211JZ, 22A0212JZ, 22A0213JZ, 22A1276JZ, 22A1277JZ, 22A1278JZ, 22B1415JZ, 22B1416JZ, 22B1417JZ, 22B1418JZ, 22B1419JZ, 22B1420JZ, 22B1421JZ, 22B1422JZ, 22B1423JZ, 22B1424JZ, 22B1425JZ, 22B1426JZ, 22D0336JZ, 22D0337JZ, 22D0338JZ, 22D0339JZ, 22D0683JZ, 22E0308JZ, 22E0309JZ, 22E0310JZ, 22E0311JZ, 22E0312JZ, 22E0313JZ, 22E0314JZ, 22E0315JZ, 22E0316JZ, 22E0317JZ, 22E0318JZ, 22E0319JZ, 22E1478JZ, 22E1479JZ, 22E1480JZ, 22E1481JZ, 22E1482JZ, 22E1483JZ, 22E1484JZ, 22E1485JZ, 22E1486JZ, 22E1487JZ, 22E1488JZ, 22E1489JZ, 22K1146JZ, 22K1147JZ, 22K1148JZ, 22K1149JZ, 22K1150JZ, 22K1151JZ, 22K1152JZ, 22K1153JZ, 22K1154JZ, 22K1155JZ, 22K1156JZ, 22L0748JZ, 22L0749JZ, 22L0750JZ, 22L0751JZ, 22L0752JZ, 22L0753JZ, 22L0754JZ, 22L0755JZ, 22L0756JZ, 22L0757JZ, 22L0758JZ, 22L0759JZ, 23B0296JZ, 23B1246JZ, 23B1247JZ, 23B1248JZ, 23B1249JZ, 23B1250JZ, 23B1251JZ, 23B1252JZ, 23B1253JZ, 23B1254JZ, 23B1255JZ, 23B1256JZ, 23B1257JZ, 23C1348JZ, 23C1349JZ, 23C1350JZ, 23C1351JZ, 23C1352JZ, 23C1353JZ, 23D0122JZ, 23D0123JZ);  MVAIHH/10884521762008(C210415652, C210736858, C211102393, C220103628, C220210317, C220216550, C220321225, C220540987, C220540991, C220649323, C220751604, C220858507, C220865635, C220974775, C221193706, C230103886, C230521272, C230627862, C230943371, C230943373, C231156185, C240208658, C240311963, C240417208, C240521264, C240624405, C240729894, C240731161, C240832775, C240935709, C241100832, D181137005, D181137006, D181137007, D201158925, D211157164, D220100665, D220632504, D220632506, D220635655, D220944770);  MVAIHL/10884521761933(C210314318, C210736813, C210961351, C211195913, C211209800, C220101632, C220210071, C220320712, C220540828, C220540830, C220540833, C220642990, C220649104, C220751446, C220861855, C220974777, C221087383, C230103644, C230211797, C230313078, C230519787, C230519980, C230520042, C230523261, C230625415, C231051553, C240103213, C240207696, C240313626, C240520095, C240521087, C240626636, C240731163, C240832777, C241038133, D191172608, D201158964, D201262155, D201262156, D201263401, D210311397, D210517014, D210837906, D210946049, D220317742);  MVAIL/20884521761909(C230211736, C240519169, C240521074, D191172604, D210104124), 10884521761902(C201100339, C201100340, C201100341, C201200367, C210207222, C210314241, C210736197, C210952345, C211063328, C211101173, C211206566, C220103206, C220103207, C220210008, C220430747, C220430749, C220538967, C220754686, C220974769, C221295517, C230103847, C230104972, C230211736, C230417429, C230519780, C230627662, C230730682, C230733056, C230943213, C230944414, C231048757, C231157389, C231158559, C231158560, C231158562, C240100227, C240519169, C240521074, C240628668, C240933083, C241037680, D191172604, D201158960, D201261418, D210104124, D210517012, D210725658, D210946047, D211153870, D211157186, D211157912, D220207963, D220318424, D220529189, D220635679);  MVAMSK/10884521783997(C211085718, C220213294, C220754930, C220971007, C221082004, C230206366, C230624523);  MVASK/10884521783980(C210525106, C211085609, C220863141, C220969758, C221293902, C221294087, D200432255, D211156488, D220104893, D220104894);  ZMVAIH/20884521762258(M230500059);  ZMVAIHH/20884521762265(M240100079);  ZMVAI/20884521771762(M221200053, M230500056)

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide - US Nationwide distribution including in the states of TX, OH, FL, CO, IL, CA, MD, PA, VA, WI, IN, MI, NY, GA, OR, SC, NC, PR, AZ, KY, AR, TN, MO, DE, MA, MS, UT, DC, NE, IA, WV, NJ, KS, LA, WA, HI, MN, AL, ME, RI, OK, MT, ID, CT, NH, AK, NV, SD, WY, ND, NM and the countries of Algeria, Andorra, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, Northern Ireland, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Virgin Islands, U.S.

Recall record

Recalling firm: Oridion Medical 1987 Ltd.
Product type: Devices
Recall number: Z-1384-2025
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Jerusalem, N/A
Recall initiated: 2025-02-17

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-1384-2025 · Source: openFDA enforcement.