Oridion Medical 1987 Ltd.: 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;

Recall number

Z-1384-2025

Recalling firm

Oridion Medical 1987 Ltd.

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;

Status

Open, Classified

Initiated

2025-02-17

Posted

2025-03-17

Terminated

not on file

Reason

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.

Root cause

Labeling design

Action

On 2/17/2025, correction notices were mailed to Risk Manager, Director of Respiratory Care, Director of Anesthesiology who were informed of the following: In September 2025, the firm will issue an update to the Instructions for Use (IFUs) for the The following IFU's: 01158, PT00156355, PT00156254, PT00156250 stating: Adverse events associated with attaching and detaching the airway adapter from the breathing circuit are listed in descending order of severity: unintended extubation, respiratory failure, hypoxia, low oxygen saturation, aspiration/inhalation and delay to treatment. Any serious incident related to device use that may occur should be reported immediately to the manufacturer, the local competent authority, and any other regulators as required. Pass on and post this notice for all those who need to be aware within your organization and to any organization where the affected product has been transferred or distributed. Complete and return the Customer Confirmation Form to rs.gmbmitgfca@medtronic.com Adverse reactions or quality problems experienced with this product should be reported to the firm's Quality Assurance at 800-255-6774 option 1, then option 1. If you have questions contact the firm's Customer Service at 800-962-9888, Option 2. On 5/13/2025, additional correction notices identifying additional affected devices were mailed to additional customers.

Quantity

8435772

Distribution

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.

Lot, serial or model codes

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, 21J0127JZ, 21J0128JZ, 21J0129JZ, 21J0130JZ, 21J0131JZ, 21J0164JZ, 21J1242JZ, 21J1243JZ, 21J1244JZ, 21J1245JZ, 21J1246JZ, 21J1247JZ, 21J1248JZ, 21J1249JZ, 21J1250JZ, 21J1251JZ, 21J1252JZ, 21K0570JZ, 21K0571JZ, 21K0572JZ, 21K0573JZ, 21K0579JZ, 21K0580JZ, 21K0581JZ, 21K0582JZ, 21K0583JZ, 21K0584JZ, 21K0585JZ, 21K0586JZ, 21K0587JZ, 21K0588JZ, 21K0589JZ, 21L0876JZ, 21L0877JZ, 21L0878JZ, 21L0879JZ, 21L0880JZ, 22A0225JZ, 22A0226JZ, 22A0227JZ, 22A0228JZ, 22A0229JZ, 22A0230JZ, 22A0231JZ, 22A0232JZ, 22A1092JZ, 22A1093JZ, 22A1250JZ, 22A1251JZ, 22A1252JZ, 22A1253JZ, 22A1254JZ, 22A1255JZ, 22A1257JZ, 22A1258JZ, 22A1259JZ, 22A1260JZ, 22A1261JZ, 22B0323JZ, 22B0324JZ, 22B0325JZ, 22B0326JZ, 22B0327JZ, 22B0328JZ, 22B0329JZ, 22B0330JZ, 22B0331JZ, 22C0577JZ, 22C0578JZ, 22C1713JZ, 22C1716JZ, 22D0248JZ, 22D0249JZ, 22D0250JZ, 22D0306JZ, 22D0307JZ, 22D0308JZ, 22D0309JZ, 22D0681JZ, 22D0682JZ, 22E0320JZ, 22E0321JZ, 22E0322JZ, 22E0344JZ, 22E0345JZ, 22E0346JZ, 22E0347JZ, 22E0348JZ, 22E0349JZ, 22E1490JZ, 22E1491JZ, 22E1492JZ, 22E1493JZ, 22E1494JZ, 22E1495JZ, 22E1496JZ, 22E1497JZ, 22E1498JZ, 22E1499JZ, 22E1499JZ, 22E1500JZ, 22E1501JZ, 22E1502JZ, 22E1503JZ, 22E1504JZ, 22E1504JZ, 22E1628JZ, 22E1629JZ, 22E1630JZ, 22G0092JZ, 22G0092JZ, 22G0093JZ, 22G0094JZ, 22G0095JZ, 22G0095JZ, 22G0096JZ, 22G0097JZ, 22G0097JZ, 22G0098JZ, 22G0099JZ, 22G0100JZ, 22G0101JZ, 22G0102JZ, 22G0102JZ, 22G0121JZ, 22G0949JZ, 22G0950JZ, 22G0989JZ, 22I0466JZ, 22I0467JZ, 22I0468JZ, 22I0469JZ, 22I0470JZ, 22I0471JZ, 22I0472JZ, 22I0472JZ, 22I0473JZ, 22I0475JZ, 22I0477JZ, 22I0478JZ, 22I0479JZ, 22I0479JZ, 22I0480JZ, 22I0481JZ, 22I0482JZ, 22I0501JZ, 22J0471JZ, 22J0472JZ, 22J0473JZ, 22J0474JZ, 22J0475JZ, 22J0476JZ, 22J0477JZ, 22J0478JZ, 22J0479JZ, 22J0480JZ, 22J0481JZ, 22J0482JZ, 22J0846JZ, 22J0847JZ, 22J0848JZ, 22J0849JZ, 22J0850JZ, 22J0851JZ, 22K0827JZ, 22K0828JZ, 22K0829JZ, 22K0830JZ, 22K0831JZ, 22K0832JZ, 22K0833JZ, 22K0834JZ, 22K0835JZ, 22K0836JZ, 22K0837JZ, 22K0838JZ, 22K1939JZ, 22K1940JZ, 22K1940JZ, 22K1941JZ, 22K1942JZ, 22K1943JZ, 22K1944JZ, 22K1945JZ, 22K1946JZ, 22K1947JZ, 22K1948JZ, 22K1949JZ, 22K1950JZ, 22K1951JZ, 22L0719JZ, 22L0720JZ, 22L0721JZ, 22L0722JZ, 22L0723JZ, 22L0724JZ, 22L0725JZ, 22L0726JZ, 22L0727JZ, 22L0728JZ, 22L0729JZ, 22L0730JZ, 22L0731JZ, 22L0732JZ, 22L0733JZ, 22L0734JZ, 22L0735JZ, 23A0696JZ, 23A0697JZ, 23A0698JZ, 23A0699JZ, 23A0700JZ, 23A0701JZ, 23A0702JZ, 23A0703JZ, 23A0704JZ, 23A0705JZ, 23A0706JZ, 23A0707JZ, 23B1241JZ, 23B1242JZ, 23B1243JZ, 23B1244JZ, 23D0126JZ, 23D0126JZ, 23D0127JZ, 23D0127JZ, 23D0128JZ, 23D0129JZ, 23D0130JZ, 23D0131JZ, 23D0132JZ, 23D0133JZ, 23D0134JZ, 23D0135JZ, 23D0136JZ, 23D0137JZ, 23F0227JZ, 23F0228JZ, 23F0229JZ, 23F0230JZ, 23F0231JZ, 23F0232JZ, 23F0233JZ, 23F0234JZ, 23F0235JZ, 23F0236JZ, 23F0237JZ, 23F0238JZ, 23F0239JZ, 23F0240JZ, 23F0241JZ, 23F0242JZ, 23F0243JZ, 23F0244JZ, 23F0245JZ, 23F0246JZ, 23H0004JZ, 23H0005JZ, 23H0708JZ, 23H0708JZ, 23I0237JZ, 23I0238JZ, 23I0734JZ, 23I0735JZ, 23I0736JZ, 23I0737JZ, 23I0738JZ, 23J0388JZ, 23J0389JZ, 23J0390JZ, 23K0518JZ, 23K0519JZ, 23K0520JZ, 23K0521JZ, 23L1114JZ, 23L1115JZ, 23L1116JZ, 23L1117JZ, 23L1118JZ, 23L1119JZ, 23L1120JZ, 23L1173JZ, 23L1174JZ, 23L1175JZ, 23L1176JZ, 24A0945JZ, 24A0946JZ, 24A0947JZ, 24A0948JZ, 24A0949JZ, 24B0361JZ, 24B1109JZ, 24B1110JZ, 24B1111JZ, 24B1112JZ, 24B1113JZ, 24C0298JZ, 24C0299JZ, 24C0300JZ, 24C0301JZ, 24E0252JZ, 24E0253JZ, 24E0254JZ, 24E0255JZ, 24E0257JZ, 24E0258JZ, 24E0259JZ, 24E0260JZ, 24E0261JZ, 24E0491JZ, 24G1239JZ, 24G1240JZ, 24G1241JZ, 24G1242JZ, 24G1243JZ, 24G1244JZ, 24G1245JZ, 24H1091JZ, 24H1092JZ, 24H1093JZ, 24H1094JZ, 24H1094JZ, 24H1095JZ, 24H1096JZ, 24H1097JZ, 24H1098JZ, 24I0518JZ, 24I0521JZ, 24I1067JZ, 24I1068JZ, 24I1069JZ, 24I1070JZ, 24I1071JZ, 24I1072JZ, 24I1073JZ, 24I1074JZ, 24I1075JZ, 24J1146JZ, 24J1147JZ, 24J1148JZ, 24J1149JZ, 24J1150JZ, 24J1151JZ, 24J1152JZ, 24J1153JZ, 24J1154JZ, 24J1155JZ, 24K0917JZ, 24K0918JZ, 24K0919JZ, 24K0920JZ, 24K0921JZ, 24L0926JZ, 24L0927JZ); MVAI100U/20884521761893(D201262882), 10884521761896(C201200394, C220861807, C220865392, C220974771, C221189671, C230519782, C230733059, C240104042, C240204822, C240205548, C240313617, D200100348, D200313711, D200314544, D201262882, D210206032, 20G0602JZ, 21A0818JZ, 21A0819JZ, 21A0823JZ, 21B0737JZ, 21C0184JZ, 21C0921JZ, 21K0574JZ, 21K0575JZ, 21K0576JZ, 21K0577JZ, 22A0216JZ, 22A0217JZ, 22A0218JZ, 22A0219JZ, 22A0220JZ, 22A0221JZ, 22A0222JZ, 22A0223JZ, 22A1262JZ, 22A1263JZ, 22A1264JZ, 22A1265JZ, 22A1266JZ, 22A1267JZ, 22A1268JZ, 22A1270JZ, 22A1271JZ, 22A1273JZ, 22B1199JZ, 22B1200JZ, 22B1201JZ, 22B1202JZ, 22B1203JZ, 22B1204JZ, 22B1205JZ, 22B1206JZ, 22B1207JZ, 22B1208JZ, 22B1209JZ, 22B1210JZ, 22B1211JZ, 22B1427JZ, 22B1428JZ, 22B1429JZ, 22B1430JZ, 22B1431JZ, 22B1434JZ, 22B1436JZ, 22B1440JZ, 22C0307JZ, 22C0308JZ, 22C0309JZ, 22C1711JZ, 22C1712JZ, 22C1714JZ, 22C1715JZ, 22D0621JZ, 22D0622JZ, 22D0623JZ, 22D0624JZ, 22E0323JZ, 22E0324JZ, 22E0325JZ, 22E0326JZ, 22E0327JZ, 22E0328JZ, 22E0329JZ, 22E0330JZ, 22E0335JZ, 22E0336JZ, 22E0337JZ, 22E0338JZ, 22E0339JZ, 22E0340JZ, 22E0341JZ, 22E0343JZ, 22G0103JZ, 22G0104JZ, 22G0105JZ, 22G0106JZ, 22G0107JZ, 22G0108JZ, 22G0109JZ, 22G0110JZ, 22G0111JZ, 22G0112JZ, 22G0113JZ, 22G0114JZ, 22G0115JZ, 22G0116JZ, 22G0117JZ, 22G0118JZ, 22G0119JZ, 22G0120JZ, 22G0951JZ, 22G0952JZ, 22G0954JZ, 22H0181JZ, 22H0182JZ, 22H0183JZ, 22H0184JZ, 22H0185JZ, 22H0186JZ, 22H0187JZ, 22H0188JZ, 22H0189JZ, 22H0190JZ, 22H0191JZ, 22H0192JZ, 22H0193JZ, 22H0194JZ, 22H0195JZ, 22H0196JZ, 22H0197JZ, 22H0198JZ, 22H0199JZ, 22H0200JZ, 22H0201JZ, 22H0202JZ, 22H0203JZ, 22H0204JZ, 22H1258JZ, 22H1259JZ, 22H1260JZ, 22H1261JZ, 22H1262JZ, 22H1263JZ, 22H1264JZ, 22H1265JZ, 22H1266JZ, 22H1267JZ, 22H1268JZ, 22H1269JZ, 22H1270JZ, 22I0370JZ, 22I0371JZ, 22I0372JZ, 22I0458JZ, 22I0461JZ, 22I0462JZ, 22I0483JZ, 22I0484JZ, 22I0485JZ, 22I0486JZ, 22I0487JZ, 22I0488JZ, 22I0489JZ, 22I0490JZ, 22I0491JZ, 22I0492JZ, 22I0493JZ, 22I0494JZ, 22I0495JZ, 22J0866JZ, 22J0867JZ, 22J0868JZ, 22J0869JZ, 22J0870JZ, 22J0871JZ, 22J0872JZ, 22J0873JZ, 22K0373JZ, 22K0374JZ, 22K0375JZ, 22K0376JZ, 22K0377JZ, 22K0378JZ, 22K0379JZ, 22K0380JZ, 22K0819JZ, 22K0820JZ, 22K0821JZ, 22K0822JZ, 22K0823JZ, 22K0824JZ, 22K0825JZ, 22K0826JZ, 22K1928JZ, 22K1929JZ, 22K1930JZ, 22K1931JZ, 22K1932JZ, 22K1933JZ, 22K1934JZ, 22K1935JZ, 22K1936JZ, 22K1937JZ, 22K1938JZ, 23B0141JZ, 23B0293JZ, 23B0294JZ, 23B0295JZ, 23B0593JZ, 23B0594JZ, 23B0595JZ, 23B0596JZ, 23B0597JZ, 23B0598JZ, 23B1258JZ, 23B1259JZ, 23B1260JZ, 23B1261JZ, 23B1262JZ, 23B1263JZ, 23B1264JZ, 23B1265JZ, 23B1266JZ, 23B1267JZ, 23B1268JZ, 23B1269JZ, 23B1270JZ, 23B1271JZ, 23B1272JZ, 23B1273JZ, 23B1274JZ, 23B1275JZ, 23D0148JZ, 23D0149JZ, 23D0150JZ, 23D0151JZ, 23D0152JZ, 23D0153JZ, 23D0154JZ, 23D0155JZ, 23D0156JZ, 23D0157JZ, 23D0158JZ, 23D0159JZ, 23E0448JZ, 23E0449JZ, 23E0450JZ, 23E0451JZ, 23E0452JZ, 23E0453JZ, 23E0454JZ, 23E0455JZ, 23E0456JZ, 23E0457JZ, 23F0209JZ, 23F0210JZ, 23F0211JZ, 23F0212JZ, 23F0213JZ, 23F0214JZ, 23F0215JZ, 23F0216JZ, 23F0217JZ, 23F0218JZ, 23F0219JZ, 23F0220JZ, 23L1113JZ, 24C0388JZ, 24C0389JZ, 24C0390JZ, 24C0391JZ, 24E0262JZ, 24E0263JZ, 24E0264JZ, 24E1489JZ, 24E1490JZ, 24E1491JZ, 24E1492JZ, 24E1493JZ, 24E1494JZ, 24E1495JZ, 24E1496JZ, 24E1497JZ, 24E1498JZ, 24E1499JZ, 24E1500JZ, 24E1501JZ, 24E1502JZ, 24E1503JZ, 24E1504JZ, 24E1505JZ, 24E1506JZ, 24F0582JZ, 24F0583JZ, 24E1586JZ, 24E1588JZ); MVAIH/10884521761919(C210314324, C211072071, C211195928, C220649131, C220866640, C220974767, C221192805, C221295586, C230103669, C230521102, C230523237, C230627658, C230733048, C230940144, C230944408, C231157382, C240522592, C240728987, C240731157, C240832565, D191172570, D201158944, D201261393, D201262844, D210205985, D210311389, D210415747, D210519534, D210837204, D210940202, D210940984, D210942597, D210944281, D211046881, 20G0603JZ, 21A0812JZ, 21A0813JZ, 21A0814JZ, 21A0815JZ, 21C0185JZ, 21C0186JZ, 21C0920JZ, 21G0529JZ, 21J0110JZ, 21J0111JZ, 21J0112JZ, 21J0113JZ, 21J0114JZ, 21J1168JZ, 21J1169JZ, 21J1170JZ, 21J1171JZ, 21J1172JZ, 21K0565JZ, 21K0578JZ, 22A0204JZ, 22A0205JZ, 22A0206JZ, 22A0224JZ, 22A1081JZ, 22A1229JZ, 22A1230JZ, 22A1231JZ, 22A1233JZ, 22A1234JZ, 22A1236JZ, 22A1237JZ, 22B1175JZ, 22B1176JZ, 22B1177JZ, 22B1178JZ, 22B1184JZ, 22B1186JZ, 22C0312JZ, 22D0247JZ, 22D0251JZ, 22D0252JZ, 22D0253JZ, 22D0254JZ, 22D0314JZ, 22D0315JZ, 22D0316JZ, 22D0317JZ, 22D0318JZ, 22D0319JZ, 22D0320JZ, 22D0321JZ, 22D0322JZ, 22D0323JZ, 22D0324JZ, 22D0325JZ, 22D0326JZ, 22D0327JZ, 22D0328JZ, 22D0329JZ, 22E0307JZ, 22E1458JZ, 22E1459JZ, 22E1460JZ, 22E1461JZ, 22E1462JZ, 22E1463JZ, 22E1464JZ, 22E1465JZ, 22E1466JZ, 22E1467JZ, 22E1468JZ, 22E1469JZ, 22E1470JZ, 22E1471JZ, 22E1472JZ, 22E1473JZ, 22E1474JZ, 22E1475JZ, 22E1476JZ, 22E1477JZ, 22F1180JZ, 22G0075JZ, 22G0076JZ, 22G0077JZ, 22G0078JZ, 22G0079JZ, 22G0080JZ, 22G0081JZ, 22G0082JZ, 22G0083JZ, 22G0084JZ, 22H0168JZ, 22H0169JZ, 22H0170JZ, 22H0171JZ, 22H0172JZ, 22H0173JZ, 22H0174JZ, 22H0175JZ, 22H0176JZ, 22H0177JZ, 22H0178JZ, 22H0179JZ, 22H0653JZ, 22H0654JZ, 22H0655JZ, 22H0656JZ, 22H0657JZ, 22H0658JZ, 22H0659JZ, 22H0660JZ, 22I0263JZ, 22I0264JZ, 22I0265JZ, 22I0266JZ, 22I0267JZ, 22I0268JZ, 22J0150JZ, 22J0151JZ, 22J0152JZ, 22J0153JZ, 22J0854JZ, 22J0855JZ, 22J0856JZ, 22J0857JZ, 22J0858JZ, 22J0859JZ, 22J0860JZ, 22J0861JZ, 22J0862JZ, 22J0863JZ, 22J0864JZ, 22J0865JZ, 22K0839JZ, 22K0840JZ, 22K0841JZ, 22K0842JZ, 22K0843JZ, 22K0844JZ, 22K0845JZ, 22K0846JZ, 22K0847JZ, 22K0848JZ, 22K0849JZ, 22K0850JZ, 22K0851JZ, 22K0852JZ, 22K1952JZ, 22K1953JZ, 22K1954JZ, 22K1955JZ, 22K1956JZ, 22K1957JZ, 22K1958JZ, 22K1959JZ, 22L0736JZ, 22L0737JZ, 22L0738JZ, 22L0739JZ, 22L0740JZ, 22L0741JZ, 22L0742JZ, 22L0743JZ, 22L0744JZ, 22L0745JZ, 22L0746JZ, 22L0747JZ, 23A0711JZ, 23A0712JZ, 23A0713JZ, 23A0714JZ, 23A0715JZ, 23A0716JZ, 23A0717JZ, 23A0718JZ, 23A0719JZ, 23A0720JZ, 23A0721JZ, 23A0722JZ, 23A0723JZ, 23A0724JZ, 23A0725JZ, 23A0726JZ, 23A0727JZ, 23B1234JZ, 23B1235JZ, 23B1236JZ, 23B1237JZ, 23B1238JZ, 23B1239JZ, 23B1240JZ, 23D0138JZ, 23D0139JZ, 23D0140JZ, 23D0141JZ, 23D0142JZ, 23D0143JZ, 23D0144JZ, 23D0145JZ, 23D0146JZ, 23F0260JZ, 23F0261JZ, 23F0262JZ, 23F0263JZ, 23F0264JZ, 23F0265JZ, 23F0266JZ, 23F0267JZ, 23F0268JZ, 23F0269JZ, 23F0270JZ, 23F0271JZ, 23F0272JZ, 23F0273JZ, 23F0274JZ, 23G0576JZ, 23G0577JZ, 23G0578JZ, 23G0586JZ, 23G0587JZ, 23G0588JZ, 23G0589JZ, 23G0590JZ, 23H0528JZ, 23H0529JZ, 23H0530JZ, 23H0531JZ, 23H0701JZ, 23H0702JZ, 23H0703JZ, 23H0704JZ, 23H0705JZ, 23H0706JZ, 23H0707JZ, 23I0235JZ, 23I0236JZ, 23I0509JZ, 23I0510JZ, 23I0511JZ, 23I0512JZ, 23I0513JZ, 23I0665JZ, 23I0666JZ, 23I0667JZ, 23I0668JZ, 23I0669JZ, 23I0670JZ, 23I0671JZ, 23I0672JZ, 23I0673JZ, 23I0674JZ, 23I0675JZ, 23J0377JZ, 23J0378JZ, 23J0379JZ, 23J0380JZ, 23J0381JZ, 23J0382JZ, 23J0383JZ, 23J0384JZ, 23J0385JZ, 23J0386JZ, 23J0387JZ, 23K0510JZ, 23K0511JZ, 23K0512JZ, 23K0513JZ, 23K0514JZ, 23K0515JZ, 23K0516JZ, 23K0517JZ, 23K1194JZ, 23L0326JZ, 23L0327JZ, 23L0328JZ, 24A0938JZ, 24A0939JZ, 24A0940JZ, 24A0941JZ, 24A0942JZ, 24A0943JZ, 24A0944JZ, 24B0383JZ, 24B0388JZ, 24B0389JZ, 24B0497JZ, 24B0498JZ, 24B0499JZ, 24B1102JZ, 24B1103JZ, 24B1104JZ, 24B1105JZ, 24B1106JZ, 24B1107JZ, 24B1108JZ, 24E0265JZ, 24E0522JZ, 24E0523JZ, 24E0524JZ, 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)

510(k) numbers

["K181467"]

PMA numbers

not on file

Product code

CCK

Firm FEI

3001227743

Firm city

Jerusalem

Firm state

Har Hotzvim Industrial Park

Firm country

Israel

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy