{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Jerusalem",
      "state": "N/A",
      "country": "Israel",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "96309",
      "recalling_firm": "Oridion Medical 1987 Ltd.",
      "address_1": "Har Hotzvim Industrial Park Box 45025",
      "address_2": "Har Hotzvim Industrial Park",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "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_number": "Z-1377-2025",
      "product_description": "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.",
      "product_quantity": "5125183",
      "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.",
      "recall_initiation_date": "20250217",
      "center_classification_date": "20250317",
      "report_date": "20250326",
      "code_info": "Part Number and Revision - REF/UDI-DI(Lot): MQ04616 Rev N -   007737/20884521551784(C210417261, C211105048, C211195967, C220103407, D191067290, D191176261, D191280252, D191283149, D200101321, D200424621, D200430274, D200432060, D200434623, D200537510, D200949677, D200952336, D201261089, D210101553, D210102181, D210204904, D210310618, D210310620, D210516971, D210519861, D210729258);  007768/10884521554023(C210417263, C210521895, C210521896, C210521897, C210957019, C211195969, C211206703, C211213565, D191067432, D191171903, D191177363, D191280436, D191283316, D200100401, D200322342, D200426869, D200536227, D200538142, D200640949, D200744614, D200744615, D200950363, D201055939, D201260696, D210101022, D210103470, D210104022, D210310522, D210726720, D211046826);  010579/10884521551985(D191171913, D200100405, D200101489, D200640405, D200744634,19J0743JZ, 19J0744JZ, 19K0492JZ, 19K0493JZ, 19K0836JZ, 20A0041JZ, 20A0042JZ, 20A0043JZ, 20A0044JZ, 20A0667JZ, 20A0668JZ, 20A0669JZ, 20A0670JZ, 20A0671JZ, 20B0176JZ, 20B0177JZ, 20B0664JZ, 20B0665JZ, 20B0666JZ, 20B0667JZ, 20B0668JZ, 20B0669JZ, 20B0670JZ, 20B0671JZ, 20B0672JZ, 20B0673JZ, 20B0674JZ, 20B0675JZ, 20B0676JZ, 20C0658JZ, 20C0659JZ, 20C0660JZ, 20C0661JZ, 20D0106JZ, 20D0107JZ, 20D0108JZ, 20E0222JZ, 20E0799JZ, 20E0800JZ, 20E0801JZ, 20E0802JZ, 20E0803JZ, 20E0804JZ, 20G0032JZ, 20G0033JZ, 20G0035JZ, 20G0479JZ, 20G0480JZ, 20G0481JZ, 20G0482JZ, 20G0486JZ, 20G0839JZ, 20G0840JZ, 20G0881JZ, 20G0882JZ, 20H0325JZ, 20H0326JZ, 20H0327JZ, 20H0328JZ, 20H0587JZ, 20H0588JZ, 20H0854JZ, 20H0855JZ, 20H0856JZ, 20H0857JZ, 20H0858JZ, 20H0859JZ, 20H0860JZ, 20H0861JZ, 20I0728JZ, 20I0858JZ, 20I0859JZ, 20I0860JZ, 20I0861JZ, 20I0862JZ, 20I0863JZ, 20I0864JZ, 20I0865JZ, 20J0882JZ, 20J0885JZ, 20J0886JZ, 20J0887JZ, 20J0888JZ, 20J0889JZ, 20J0912JZ, 20J0913JZ, 20K0110JZ, 20K0424JZ, 20K0425JZ, 20K0582JZ, 20K0583JZ, 20K0584JZ, 20K0585JZ, 20L0141JZ, 20L0142JZ, 20L0143JZ, 20L0144JZ, 20L0503JZ, 20L0504JZ, 20L0505JZ, 21A0677JZ, 21A0678JZ, 21A0679JZ, 21B0258JZ, 21B0259JZ, 21B0776JZ, 21B0777JZ, 21C0164JZ, 21C0165JZ, 21C0166JZ, 21C0167JZ, 21D0186JZ, 21D0192JZ, 21E0056JZ, 21E0057JZ, 21E1381JZ, 21E1382JZ, 21E1383JZ, 21E1384JZ, 21E1385JZ, 21E1386JZ, 21E1387JZ, 21G0380JZ, 21G0381JZ, 21G0382JZ, 21G0383JZ, 21G0963JZ, 21G0964JZ, 21H0044JZ, 21H0045JZ, 21H0601JZ, 21H0602JZ, 21H0603JZ, 21H0604JZ, 21H0740JZ, 21H1069JZ, 21H1070JZ, 21H1071JZ, 21H1072JZ, 21H1073JZ, 21H1074JZ, 21H1075JZ, 21H1076JZ, 21H1077JZ, 21H1078JZ, 21H1080JZ, 21H1081JZ, 21I0523JZ, 21I0524JZ, 21I0684JZ, 21I0685JZ, 21J0105JZ, 21J0106JZ, 21J0107JZ, 21J0108JZ, 21J1164JZ, 21J1165JZ, 21J1166JZ, 21J1167JZ, 21K0557JZ, 21K0558JZ, 21K0559JZ, 21K0560JZ, 21K0561JZ, 21K0562JZ), A8845215519803(19K0297JZ, 19K0298JZ, 19K0487JZ, 19K0488JZ, 19K0489JZ, 19K0490JZ, 19K0491JZ, 19K0492JZ), 10884521551992(19K0024JZ, 20B0968JZ, 20C0394JZ, 20C0927JZ), 009865(19J0754JZ, 19K0024JZ); 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}