Key facts
| Recalling firm | Insulet Corporation |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 |
| Classification | Class I |
| Recall number | Z-1797-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| 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. |
What consumers should do
Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Specifically, check whether the product in your possession matches the description on file with FDA -- Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 -- and the recall number Z-1797-2026. If it matches, stop using or distributing it and contact Insulet Corporation or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
What this classification means
FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification. In this case, the recalling firm is Insulet Corporation and the affected product is described in FDA's record as: Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7. FDA's stated reason for the recall is: 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 (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-1797-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
Insulet Corporation’s FDA history
Argus HQ has recorded 1 total FDA action tied to Insulet Corporation: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- What should someone who has this product do?
- Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Check the product against FDA's description (Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7) and recall number Z-1797-2026, then follow Insulet Corporation's recall instructions.
- Has Insulet Corporation had other FDA recalls or enforcement actions?
- This is the only FDA action Argus HQ has on file for Insulet Corporation so far. Argus ingests new FDA enforcement records daily.
- What is the FDA recall number for this event?
- FDA recall number Z-1797-2026.
- What is the current status of this recall?
- Status as recorded by FDA: Ongoing.
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Related enforcement actions
Full FDA history for Insulet CorporationCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Class I Recall: Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK… by Insulet Corporation. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-insulet-corporation-z-1797-2026
"FDA Class I Recall: Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK… by Insulet Corporation." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-insulet-corporation-z-1797-2026.
Argus HQ Research. "FDA Class I Recall: Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK… by Insulet Corporation." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-insulet-corporation-z-1797-2026.
@misc{argushq_argushq_ai_recall_fda_recall_insulet_corporation_z_1797_2026_2026,
title = {FDA Class I Recall: Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK… by Insulet Corporation},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/recall/fda-recall-insulet-corporation-z-1797-2026},
note = {Accessed: July 13, 2026}
}Source: FDA.gov — Recalls ↗