Class 1 Device Recall Omnipod 5 ACE Pump

• Date Initiated by Firm: March 12, 2026
• Date Posted: April 10, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1797-2026
• Recall Event ID: 98586
• 510(K)Number: K231826
• Product Classification: Alternate controller enabled insulin infusion pump - Product Code QFG
• Product: Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
• Code Information: Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7. UDI-DI: 10385083000527. Lot Codes: PH1U02252541, PH1U03282511, PH1U03282522, PH1U03312511, PH1U03312521, PH1U04012511, PH1U04012521, PH1U05052511, PH1U08162531, PH1U08182531, PH1U08182541, PH1U09242511, PH1U09242521, PH1U09242531, PH1U09252521, PH1U09252531, PH1U10152541, PH1U10162531, PH1U10162541, PH1U10172531, PH1U10172541, PH1U10182531, PH1U10182541, PH1U10202511, PH1U10202521, PH1U10202531, PH1U10202541, PH1U10212531, PH1U10212541, PH1U10222531, PH1U10222541, PH1U10232531, PH1U10232541, PH1U10242521, PH1U10242531, PH1U10242541.
• FEI Number: 3014585508
• Recalling Firm/ Manufacturer: Insulet Corporation; 50 & 100 Nagog Park; Acton MA 01720-3440
• For Additional Information Contact: Julie Perkins; 978-600-7451
• Manufacturer Reason for Recall: Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to the unexposed portion of the soft cannula during manufacturing, which would result in a compromised fluid path. The primary failure mode is pump under-delivery due to loss of insulin to an internal leak; in some cases, the defect may also lead to pump shutoff and cessation of insulin delivery when leaked insulin contacts Pod circuity in a manner that results in an electrical short. Under-delivery of insulin (both basal and bolus insulin) or cessation of insulin put users at risk of hyperglycemia, and complications from acute and chronic hyperglycemia, including dehydration, blurry vision, nausea, vomiting, altered mental status, diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death. Users may require hospitalization or medical intervention to treat severe adverse health consequences. Not all devices with the defect will issue an alarm or alert the user. If there is sufficient leakage of insulin to cause a short in the circuity, the Pod will issue a Hazard Alarm that stops all insulin delivery and alerts the user to replace their Pod. In addition, if a user s glucose is trending high and is not responding to insulin delivery, the system may reach the maximum amount of insulin microboluses allowed by the system and trigger the Automated Delivery Restriction (ADR) alert that tells users to check their blood glucose and take appropriate actions (i.e., ADR is a response to persistent hyperglycemia and maximum automated delivery constraints rather than a direct detection of the leak). The magnitude of under-delivery is unknown and based on multiple factors, including how much insulin is being delivered, whether an alarm and/or alert triggers, whether and when the user recognizes the device defect, the duration of Pod use, and the size of the tear.
• FDA Determined Cause: Process design
• Action: Insulet notified consignees via press release and letters sent via email primarily and also text message on 03/12/2026. The press release instructed users to visit omnipod.com/check-pods to confirm whether their Pod lot number is affected, discontinue use of any affected pods and replace it with a Pod from an unaffected lot. Consignees were asked to contact Insulet to arrange for the return of any affected Pods on hand. Patients were directly notified and instructed to visit omnipod.com/check-pods to acknowledge receipt and check to see if their lot is affected, DO NOT use Pods from the affected lots, discontinue use of any impacted Pod immediately, and contact Insulet to request replacement Pods and return unused Pods from affected lots. Healthcare providers were also directly notified and informed that Insulet will be replacing the pod supply for affected customers, and that if patients do experience a temporary interruption in pod supply, we are advising them to reach out to their healthcare provider for guidance on alternative insulin delivery options until replacement Pods are received. They were also advised of the communication and instructions sent to patients and were advised that if their patients contact them regarding the issue to advise them as follows: visit omnipod.com/check-pods to acknowledge receipt and check to see if their lot is affected, DO NOT use Pods from the affected lots, discontinue use of any impacted Pod immediately, and contact Insulet to request replacement Pods and return unused Pods from affected lots. For product support, replacement requests, or to report adverse events or quality concerns related to Omnipod 5 Pods, please contact Insulet Product Support at 1-800-641-2049, available 24/7.
• Quantity in Commerce: 1,240,115 units
• Distribution: Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = QFG