{"recall":{"id":"fda-device-99787","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Draeger, Inc. recalls VentStar Resus Neo","firm":"Draeger, Inc.","date":"2026-09-03","reported":"2026-10-07","status":"Ongoing","classification":"Class I","products":[{"name":"VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.","code":"Part Number MP00310. UDIDI: 04048675422358. All lot numbers.","quantity":"1,063,643 units","number":"Z-3252-2026","classification":"Class I"}],"reason":"Potential cracks in the hose, which could lead to leakage or the hose falling off.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"US Nationwide distribution including in the states of IN, AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SD, TN, TX, VT, WA, WI, WV, WY, MS, SC, UT, VA, AR, and territories AS and PR. The countries of Canada, Germany, United Kingdom, Spain, Italy, Ireland, Poland, Australia, Switzerland, Netherlands, Portugal, France, Austria, Hong Kong, Malaysia, Costa Rica, Andorra, Belgium, Sweden, Cyprus, Greece, Latvia, Romania, Albania, Moldavia, Kazakhstan, Croatia, Libya, Mauritius, Honduras, Suriname, Uruguay, Syria, Israel, Kuwait, Bahrain, Qatar, Utd.Arab.Emir., Oman, Denmark, Norway, New Zealand, Brunei Darussalam, Singapore, China, India, Japan.","nationwide":true,"states":[],"units":"1,063,643 units","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99787","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"0cf21b7f7e88b808","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99787","record":[{"status":"Ongoing","city":"Telford","state":"PA","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99787","recalling_firm":"Draeger, Inc.","address_1":"3135 Quarry Rd","address_2":"","postal_code":"18969-1042","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution including in the states of IN, AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SD, TN, TX, VT, WA, WI, WV, WY, MS, SC, UT, VA, AR, and territories AS and PR. The countries of Canada, Germany, United Kingdom, Spain, Italy, Ireland, Poland, Australia, Switzerland, Netherlands, Portugal, France, Austria, Hong Kong, Malaysia, Costa Rica, Andorra, Belgium, Sweden, Cyprus, Greece, Latvia, Romania, Albania, Moldavia, Kazakhstan, Croatia, Libya, Mauritius, Honduras, Suriname, Uruguay, Syria, Israel, Kuwait, Bahrain, Qatar, Utd.Arab.Emir., Oman, Denmark, Norway, New Zealand, Brunei Darussalam, Singapore, China, India, Japan.","recall_number":"Z-3252-2026","product_description":"VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310    Disposable breathing circuit for use with a resuscitation module.","product_quantity":"1,063,643 units","reason_for_recall":"Potential cracks in the hose, which could lead to leakage or the hose falling off.","recall_initiation_date":"20260903","center_classification_date":"20260930","report_date":"20261007","code_info":"Part Number MP00310. UDIDI: 04048675422358. All lot numbers.","more_code_info":""}]}}