{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "220614", "product_res_number": "Z-2603-2026", "event_date_initiated": "2026-05-20", "event_date_posted": "2026-06-30", "recall_status": "Open, Classified", "res_event_number": "99034", "product_code": "QFG", "k_numbers": [ "K231826" ], "product_description": "Omnipod 5 Pods. Includes the below Model/REF Numbers: \n\n1. POD-OMNI-I1-6720.\n\n2. POD-OMNI-I1-6220. \n\n3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). \n\n4. OMNI-I1-6220. \n\n5. OMNI-I1-6720. \n\n6. BLE-H1-529 (10-Pack), BLE-H1-520 (Single Pod).", "code_info": "1. Model/REF Number: POD-OMNI-I1-6720. Pack UDI-DI: 20385083000579. Single Pod UDI-DI: 10385083000527. Lot Numbers: PH1U01032521, PH1U01102521, PH1U12102421, PH1U12172421, PH1U11212421, PH1U11252421, PH1U11222421, PH1U12092421, PH1U09112421, PH1U11262421, PH1U04032521, PH1U12022421, PH1U12182421, PH1U04302524, PH1U05022521, PH1U01222521, PR1U11202533, PH1U09122421, PH1U10102421, PH1U12122421, PH1U01302522, PH1U02222521, PH1U05052521, PH1U10042421, PH1U12102412, PH1U01312521, PH1U03312521, PH1U05012521, PH1U09122422, PH1U09162421, PH1U09192421, PH1U09212421, PH1U09262411, PH1U09262421, PH1U10112422, PH1U10122421, PH1U10172421, PH1U12132422, PH1U01132521, PH1U01172521, PH1U02132511, PH1U03202521, PH1U03262521, PH1U04042521, PR1U11192531, PH1U11192511, PR1U01162621, PH1U09172421, PH1U09182421, PH1U09202421, PH1U10142421, PH1U10152421, PH1U10162421, PH1U01232522, PH1U01312511, PH1U02032521, PH1U02042521, PH1U02212521, PH1U03282521, PH1U04092521, PH1U04102521, PH1U04112521, PH1U10172522, PH1U10182521, PH1U10202521, PH1U10212521, PH1U10222521, PH1U10232521, PH1U10242521, PH1U10252521, PH1U11152521, PH1U11172511, PH1U11172521, PH1U11182521, PR1U11182531, PR1U11182541, PR1U11192541, PH1U11192521, PR1U11192532, PR1U11192542, PR1U11202521, PR1U11202532, PR1U11202541, PR1U11202542, PR1U11212521, PR1U11222531, PR1U11222541, PR1U11222521, PR1U11232541, PR1U11242521, PR1U11242531, PR1U11252541, PR1U11252512, PR1U11252521, PR1U11262521, PR1U12012521, PR1U12022521, PR1U12032521, PR1U12102522, PR1U12112521, PR1U12122521, PR1U12132511, PR1U12132521, PR1U12152521, PR1U12162521, PR1U12172521, PR1U01132621, PR1U01152621, PR1U01172621, PR1U01202621, PR1U01212621, PR1U01222621, PR1U01232621, PR1U01272621, PR1U01302641, PR1U01312631, PR1U02022641, PR1U02032631, PR1U02032641, PR1U02042641, PR1U02052631, PR1U02052641, PR1U02062631, PR1U02112641, PR1U02132611, PR1U02132641, PR1U11252531, PR1U11262541, PH1U06282422. \n\n2. Model/REF Number: POD-OMNI-I1-6220. Pack UDI-DI: 20385083000425. Single Pod UDI-DI: 10385083000411. Lot Numbers: PH1U10182422, PH1U02202521, PH1U04222521, PH1U04232511, PH1U04232521, PH1U11142521, PH1U12042521, PH1U12052521, PH1U01092621. \n\n3. Model/REF Number: OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). Pack UDI-DI: N/A. Single Pod UDI-DI: N/A. Lot Numbers: PH1U01222522. \n\n4. Model/REF Number: OMNI-I1-6220. Pack UDI-DI: 2038508300043. Single Pod UDI-DI: 10385083000411. Lot Numbers: PH1U04182521, PH1U04212521, PH1U12192411. \n\n5. Model/REF Number: OMNI-I1-6720. Pack UDI-DI: 20385083000548. Single Pod UDI-DI: 10385083000527. Lot Numbers: PH1U01022521, PH1U12202421, PH1U12192421, PH1U10212421, PH1U10232421. \n\n6. Model/REF Number: BLE-H1-529 (10-Pack), BLE-H1-520 (Single Pod). Pack UDI-DI: 20385083000135. Single Pod UDI-DI: 10385083000114. Lot Numbers: PH1U01072521, PH1U01242521, PH1U03082521, PH1U04172521, PH1U01272513.", "firm_fei_number": "3014585508", "recalling_firm": "Insulet Corporation", "address_1": "50 & 100 Nagog Park", "city": "Acton", "state": "MA", "postal_code": "01720-3440", "additional_info_contact": "978-600-7451", "reason_for_recall": "External 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.", "root_cause_description": "Process design", "action": "Insulet initially issued a press release on 05/26/2026 along with an \"Urgent: Medical Device Correction\" on the same day. Consignees were notified of the issue and hazard and instructed to not used Pods from affected lots and to check the lot number on the Pod tray lid, box or Pod itself to determine if affected Pods are on hand. If impacted Pods are on hand, consignees were instructed to discontinue use of any impacted Pod immediately, immediately change the Pod if currently using an affected lot, and acknowledge the email confirming receipt. Confirming receipt of the email is needed even if no affected Pods are on hand. Customers will receive a return kit with clear instructions on how to send back any unused affected Pods.", "product_quantity": "4,936,056 units", "distribution_pattern": "Worldwide 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.", "openfda": { "k_number": [ "K191679", "K230545", "K241078", "K252770", "K240309", "K253074", "K232380", "K253743", "K231485", "K234027", "K223213", "K233952", "K203768", "K213536", "K261672", "K231826", "K250930", "K251032", "K213134", "K233044", "K253976", "K203234", "K241178", "K201214", "DEN180058", "K250792", "K253470", "K223846" ], "registration_number": [ "3010291427", "3032746481", "2030624", "3016245399", "2032098", "3005627859", "3014197758", "3007981285", "3014585508", "2246552", "2024024", "3013756811", "3016798778", "3044561902", "1220973", "3016540876", "3015192982", "3008824097", "2029275", "2030598", "3019004087", "3026266833", "3047799708", "1220477", "2022435", "3019807891", "2032227", "3042027705", "3030970576" ], "fei_number": [ "3010291427", "3032746481", "1000306431", "3000206435", "3016245399", "3005627859", "3014197758", "3007981285", "3014585508", "2246552", "2024024", "3013756811", "3016798778", "3044561902", "1000518731", "1220973", "3003058448", "3016540876", "3015192982", "3008824097", "3019004087", "3026266833", "3047799708", "1220477", "2022435", "3019807891", "3042027705", "3003166194", "3030970576" ], "device_name": "Alternate Controller Enabled Insulin Infusion Pump", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "880.5730", "device_class": "2" } } ] }