Insulet Corporation recalls Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. PO…
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). 4. OMNI-I1-6220. 5. OMNI-I1-6720. 6. BLE-H1-529 (10-Pack), BLE-H1-520 (Single Pod)UDI-DI 20385083000579.REF Number167 affected lotsPH1U01032521PH1U01102521PH1U12102421PH1U12172421PH1U11212421PH1U11252421PH1U11222421PH1U12092421
+159 more
PH1U09112421PH1U11262421PH1U04032521PH1U12022421PH1U12182421PH1U04302524PH1U05022521PH1U01222521PR1U11202533PH1U09122421PH1U10102421PH1U12122421PH1U01302522PH1U02222521PH1U05052521PH1U10042421PH1U12102412PH1U01312521PH1U03312521PH1U05012521PH1U09122422PH1U09162421PH1U09192421PH1U09212421PH1U09262411PH1U09262421PH1U10112422PH1U10122421PH1U10172421PH1U12132422PH1U01132521PH1U01172521PH1U02132511PH1U03202521PH1U03262521PH1U04042521PR1U11192531PH1U11192511PR1U01162621PH1U09172421PH1U09182421PH1U09202421PH1U10142421PH1U10152421PH1U10162421PH1U01232522PH1U01312511PH1U02032521PH1U02042521PH1U02212521PH1U03282521PH1U04092521PH1U04102521PH1U04112521PH1U10172522PH1U10182521PH1U10202521PH1U10212521PH1U10222521PH1U10232521PH1U10242521PH1U10252521PH1U11152521PH1U11172511PH1U11172521PH1U11182521PR1U11182531PR1U11182541PR1U11192541PH1U11192521PR1U11192532PR1U11192542PR1U11202521PR1U11202532PR1U11202541PR1U11202542PR1U11212521PR1U11222531PR1U11222541PR1U11222521PR1U11232541PR1U11242521PR1U11242531PR1U11252541PR1U11252512PR1U11252521PR1U11262521PR1U12012521PR1U12022521PR1U12032521PR1U12102522PR1U12112521PR1U12122521PR1U12132511PR1U12132521PR1U12152521PR1U12162521PR1U12172521PR1U01132621PR1U01152621PR1U01172621PR1U01202621PR1U01212621PR1U01222621PR1U01232621PR1U01272621PR1U01302641PR1U01312631PR1U02022641PR1U02032631PR1U02032641PR1U02042641PR1U02052631PR1U02052641PR1U02062631PR1U02112641PR1U02132611PR1U02132641PR1U11252531PR1U11262541PH1U06282422POD-OMNI-I1-62202038508300042510385083000411PH1U10182422PH1U02202521PH1U04222521PH1U04232511PH1U04232521PH1U11142521PH1U12042521PH1U12052521PH1U01092621OMNI-I1-6729OMNI-I1-6720PH1U01222522OMNI-I1-6220203850830004310385083000411PH1U04182521PH1U04212521PH1U12192411OMNI-I1-67202038508300054810385083000527PH1U01022521PH1U12202421PH1U12192421PH1U10212421PH1U10232421BLE-H1-529BLE-H1-5202038508300013510385083000114PH1U01072521PH1U01242521PH1U03082521PH1U04172521PH1U01272513
What the firm is doing
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.
DistributionShow detailsHide
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.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2603-2026
- FDA 510(k) clearance · K231826The device's official FDA premarket clearance record
- FDA device classification · QFGOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.5730The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Insulet CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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