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FDA recall, , High risk

Insulet Omnipod 5 Pods

Omnipod 5 Pods may have a tear causing insulin to leak inside, leading to under-delivery or cessation of insulin.

Insulet lists the affected products

Its list gives the lot numbers.

Look up yours on cts.businesswire.com  (opens in a new tab)

Summary by Recall Canary from the FDA notice

What happened

Insulet Corporation, based in Acton, Massachusetts, recalled certain Omnipod 5 Pods because a manufacturing defect can cause an internal soft cannula tear, leading to insulin leaking into the Pod instead of being delivered to the user, regardless of basal or bolus delivery.

The defect results from damage to the unexposed portion of the soft cannula during manufacturing, which compromises the fluid path. The company began the recall on March 12, 2026, and the FDA added it to its Enforcement Report on April 10, 2026, with nationwide distribution.

The recalled Pods, identified as model PT-001662 ASM 5PK Pod STRL OPS G6G7, may have a small tear in the internal tubing that delivers insulin, causing it to leak inside the Pod instead of being fully infused into the body as intended. The recall covers 1,240,115 units across 49 lots.

More manufacturing problem recalls

What to do

If a code on your device is listed below:

  1. If a Pod from an affected lot is currently in use, customers should discontinue use and replace it with a Pod from an unaffected lot.
  2. Customers who have questions or need assistance may contact Insulet Product Support at 1-800-641-2049 (available 24/7) or use the live agent chat at omnipod.com/current-podders.
  3. You can visit omnipod.com/check-pods to check lot numbers and request replacement Pods at no cost.
  4. Visit omnipod.com/check-pods to confirm whether your Pod lot number is included in this voluntary Medical Device Correction and request replacement Pods at no cost.

Is yours affected?

Insulet lists the affected products and lot numbers on its website. A product missing from this page may still be recalled.

Look up your product on cts.businesswire.com/ct/CT (opens in a new tab)

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. Omnipod 5 Pods

    UDI-DI
    • 10385083000527
    Lot code
    • 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
    Model number
    PT-001662 ASM 5PK Pod STRL OPS G6G7

Recall details

Company began the recall
Sold in

Nationwide distribution.

Company
Insulet CorporationActon, Massachusetts
Hazard
Manufacturing problem
Risk

High risk

There is a reasonable chance that using it could cause serious health problems or death.

FDA Class I recall · How risk is rated

Event ID
98586
Recall number
Z-1797-2026
Quantity recalled
1,240,115 units

All recalls from Insulet Corporation

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall · Announced by the company

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. In FDA's weekly enforcement report

  4. Listed on Recall Canary

  5. Summary updated

Same product, other recalls

Summary by Recall Canary, written with AI · summary updated Oct 7, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)