{"recall":{"id":"fda-device-99100","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Medela Inc recalls Brand Name: Medela Product Name: ENFit ExSet Strl 60 2","firm":"Medela Inc","date":"2026-06-05","reported":"2026-07-08","status":"Ongoing","classification":"Class II","products":[{"name":"Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Product Description: Enteral Extension Set, Length 60 Orange-Striped Minibore Tubing, (Approx. Priming Vol. 2.00 mL), ENFit¿ Component: N/A","code":"Lot Code: Item Number ENF060182LD / 101033086; Lot Number 0000747253; Date of Manufacturing 2026-01-16; Expiration Date 2029-01-16; Carton GTIN 20020451101358; Unit GTIN 00020451101354","quantity":"82900","number":"Z-2645-2026","classification":"Class II"}],"reason":"May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US distribution to the following states: AZ, CA, CO, FL, HI, IL, IN, MD, MI, MN, MO, NC, NJ, NY,  OR, PA, TX, VA.","nationwide":false,"states":["AZ","CA","CO","FL","HI","IL","IN","MD","MI","MN","MO","NC","NJ","NY","OR","PA","TX","VA"],"units":"82900","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=99100","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"233a105c853f3804","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=99100","record":[{"status":"Ongoing","city":"Mchenry","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99100","recalling_firm":"Medela Inc","address_1":"1101 Corporate Dr","address_2":"N/A","postal_code":"60050-7006","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US distribution to the following states: AZ, CA, CO, FL, HI, IL, IN, MD, MI, MN, MO, NC, NJ, NY,  OR, PA, TX, VA.","recall_number":"Z-2645-2026","product_description":"Brand Name: Medela  Product Name: ENFit ExSet Strl 60  2.0ml PV 1ct EN  Model/Catalog Number: ENF060182LD / 101033086  Software Version: N/A  Product Description: Enteral Extension Set, Length 60  Orange-Striped Minibore Tubing,    (Approx. Priming Vol. 2.00 mL), ENFit¿  Component: N/A","product_quantity":"82900","reason_for_recall":"May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.","recall_initiation_date":"20260605","center_classification_date":"20260701","report_date":"20260708","code_info":"Lot Code: Item Number ENF060182LD / 101033086; Lot Number 0000747253; Date of Manufacturing 2026-01-16; Expiration Date 2029-01-16; Carton GTIN 20020451101358; Unit GTIN 00020451101354"}]}}