{"url_path":"/fda/device/recalls/Z-2645-2026","section_key":"summary","section_title":"DEVICE Recall: Medela Inc — 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","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-05","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2645-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Medela Inc"},"word_count":150,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2645-2026\n\n**Recalling firm:** Medela Inc\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-05\n**Report date:** 2026-07-08\n\n## Product\nBrand 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\n\n## Reason\nMay 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.\n\n## Affected lots\nLot 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\n\n## Distribution\nUS distribution to the following states: AZ, CA, CO, FL, HI, IL, IN, MD, MI, MN, MO, NC, NJ, NY,  OR, PA, TX, VA."}