{"url_path":"/fda/device/recalls/Z-2605-2026","section_key":"summary","section_title":"DEVICE Recall: Insulet Corporation — Omnipod (Eros) Pod. Includes the below Model/REF Numbers:     1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod).     2. ZXR425 (10-Pack), ZXR420 (Single Pod).     3. ZXP425 (10 Pack), ZXP420 (Single Pod).","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-20","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2605-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Insulet Corporation"},"word_count":242,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2605-2026\n\n**Recalling firm:** Insulet Corporation\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-20\n**Report date:** 2026-07-08\n\n## Product\nOmnipod (Eros) Pod. Includes the below Model/REF Numbers:     1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod).     2. ZXR425 (10-Pack), ZXR420 (Single Pod).     3. ZXP425 (10 Pack), ZXP420 (Single Pod).\n\n## Reason\nExternal soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death.\n\n## Affected lots\n1. Model/REF Number: POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). Pack UDI-DI: 20385081120033. Single Pod UDI-DI: 10385081120036. Lot Numbers: L72514.   2. Model/REF Number: ZXR425 (10-Pack), ZXR420 (Single Pod). Pack UDI-DI: N/A. Single Pod UDI-DI: N/A. Lot Numbers: L72516, L72521.   3. Model/REF Number: ZXP425 (10 Pack), ZXP420 (Single Pod). Pack UDI-DI: 20385081120033. Single Pod UDI-DI: 10385081120036. Lot Numbers: L72515, L72509, L72513, L72511, L72510, L71480, L72514.\n\n## Distribution\nWorldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Finland, France, UK, Greece, Israel, Italy, Kuwait, Leichtenstein, Netherlands, Norway, Saudi Arabia, Sweden and Turkey."}