{"recall":{"id":"fda-device-99660","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Ventec Life Systems, Inc. recalls 3 products","firm":"Ventec Life Systems, Inc.","date":"2026-07-28","reported":"2026-09-30","status":"Ongoing","classification":"Class II","products":[{"name":"HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve","code":"UDI:00850018761369/Serial #s: 24IKMA00532 24IKMA0053M 24IKMA0054N 24IKMA005G8 24IKMA005AP 24IKMA005QB 24IKMA005Q4 24IKMA005PM 24IKMA005QJ 24IKMA005QX 24IKMA005PJ 24IKMA005SW 24IKMA005RB 24IKMA00612 24IKMA0067E 24IKMA0066L 24IKMA0068U 24IKMA00685 24IKMA006AQ 24IKMA006B7 24IKMA006BG","quantity":"21 units","number":"Z-3221-2026","classification":"Class II"},{"name":"REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver","code":"UDI:00850018761352/Serial #s: 24IKMA0029J and 24IKMA002CM","quantity":"2 units","number":"Z-3222-2026","classification":"Class II"},{"name":"REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve","code":"UDI:00850018761376/ Serial #s: 25EKMA00BAC 25EKMA009L3 25EKMA009CM 25EKMA009J8 25GKMA00077 25GKMA0007B 25GKMA0009Z 25GKMA0004U 25GKMA000CS 25GKMA000CR 25GKMA000CX 25GKMA000D0 25GKMA000LL 25GKMA000N1 25GKMA000UD 25GKMA000D1 25GKMA000TN 25GKMA000D2 25GKMA000UC 25GKMA000LK 25GKMA000UA 25GKMA000UB 25GKMA000UE 25GKMA000CY 25GKMA000UF","quantity":"25 units","number":"Z-3223-2026","classification":"Class II"}],"reason":"Labeling; Oxygen Cylinders do not contain required medical gas labeling","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of FL, IA, OH, NE, TN.","nationwide":true,"states":[],"units":"21 units; 2 units; 25 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=99660","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"f5d57dc0bf926066","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=99660","record":[{"status":"Ongoing","city":"Bothell","state":"WA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99660","recalling_firm":"Ventec Life Systems, Inc.","address_1":"22002 26th Ave Se","address_2":"","postal_code":"98021-4903","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of FL, IA, OH, NE, TN.","recall_number":"Z-3221-2026","product_description":"HF2P0ST9  HomeFill Oxygen System  HomeFill Cylinder M9 with CGA870 Compatible Post Valve","product_quantity":"21 units","reason_for_recall":"Labeling; Oxygen Cylinders do not contain required medical gas labeling","recall_initiation_date":"20260728","center_classification_date":"20260918","report_date":"20260930","code_info":"UDI:00850018761369/Serial #s: 24IKMA00532 24IKMA0053M 24IKMA0054N 24IKMA005G8 24IKMA005AP 24IKMA005QB 24IKMA005Q4 24IKMA005PM 24IKMA005QJ 24IKMA005QX 24IKMA005PJ 24IKMA005SW 24IKMA005RB 24IKMA00612 24IKMA0067E 24IKMA0066L 24IKMA0068U 24IKMA00685 24IKMA006AQ 24IKMA006B7 24IKMA006BG","more_code_info":""},{"status":"Ongoing","city":"Bothell","state":"WA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99660","recalling_firm":"Ventec Life Systems, Inc.","address_1":"22002 26th Ave Se","address_2":"","postal_code":"98021-4903","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of FL, IA, OH, NE, TN.","recall_number":"Z-3222-2026","product_description":"REF:HF2PC9  HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver","product_quantity":"2 units","reason_for_recall":"Labeling; Oxygen Cylinders do not contain required medical gas labeling","recall_initiation_date":"20260728","center_classification_date":"20260918","report_date":"20260930","code_info":"UDI:00850018761352/Serial #s:  24IKMA0029J and 24IKMA002CM","more_code_info":""},{"status":"Ongoing","city":"Bothell","state":"WA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99660","recalling_firm":"Ventec Life Systems, Inc.","address_1":"22002 26th Ave Se","address_2":"","postal_code":"98021-4903","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of FL, IA, OH, NE, TN.","recall_number":"Z-3223-2026","product_description":"REF: HF2POSTD  HomeFill Oxygen System  HomeFill cylinder D with CGA870 Compatible Post Valve","product_quantity":"25 units","reason_for_recall":"Labeling; Oxygen Cylinders do not contain required medical gas labeling","recall_initiation_date":"20260728","center_classification_date":"20260918","report_date":"20260930","code_info":"UDI:00850018761376/ Serial #s: 25EKMA00BAC 25EKMA009L3 25EKMA009CM 25EKMA009J8 25GKMA00077 25GKMA0007B 25GKMA0009Z 25GKMA0004U 25GKMA000CS 25GKMA000CR 25GKMA000CX 25GKMA000D0 25GKMA000LL 25GKMA000N1 25GKMA000UD 25GKMA000D1 25GKMA000TN 25GKMA000D2 25GKMA000UC 25GKMA000LK 25GKMA000UA 25GKMA000UB 25GKMA000UE 25GKMA000CY 25GKMA000UF","more_code_info":""}]}}