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Class I (most serious) Medical Device Z-2603-2026 Ongoing

Insulin pump cannula damage (Z-2603-2026) — how to read a quantity of 4.9 million

Insulet Corporation ・Reported Jul 8, 2026

A recall began for disposable pumps worn on the body after manufacturing damage to a thin cannula allowed insulin to leak around the pod instead of reaching the user. The quantity is 4,936,056. What that figure means depends on what counts as one unit.

Recall overview (primary data)

  • ClassificationClass I (most serious)
  • Product typeMedical Device
  • Recalling firmInsulet Corporation
  • ReasonExternal 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.
  • DistributionWorldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Finland, France, UK, Greece, Israel, Italy, Kuwait, Leichtenstein, Nethe...
  • Recall initiated2026-05-20

Key points

  • Manufacturing damage to the soft outer cannula allows insulin to leak around the pod rather than reach the user.
  • The primary failure mode is under-delivery, and the stated reason names severe conditions and death among what can follow.
  • The quantity is 4,936,056 units, the class is I, and distribution covers the United States plus twenty countries.
  • The 1,408 records this site holds as of 2026-09-04 carry 1,029 distinct quantity expressions across units, cases, systems and kits.
  • The size of a quantity connects neither to how many people are affected nor to how severe the harm could be.

1What should have gone in comes out instead

The pod is worn on the body and feeds insulin steadily through a thin cannula. What the stated reason records is that the soft outer cannula can be damaged during manufacturing, so the fluid leaks around the pod rather than entering the body. It happens the same way for background delivery and for the extra given with a meal. The result is under-delivery, and blood glucose that does not come down. The reason goes on to name what can follow, up to and including death.

2The quantity field does not share a unit

Quantity in this record4,936,056Counting one disposable pod as one unit
Distinct quantity expressions among the 1,408 records this site holds as of 2026-09-041,029Almost no expression repeats
Records with no quantity given, of those same 1,408624.4%

Across 1,408 records there are 1,029 distinct ways of writing a quantity. The unit may be units, or cases, or systems, or kits, or bottles. The croutons in the previous article were 13,739 cases of twelve pouches, a figure that yields a pouch count only after multiplication. The quantity field is not built to be lined up and compared as it stands.

3What counts as one differs by product

The aspectA disposable consumableA fixed installation
One unitOne productOne system
Order of magnitudeCan reach millionsStays in the tens or hundreds
What the number showsTotal product placed on the marketNumber of installed systems
Relation to classLarge numbers can still be Class IISmall numbers can still be Class I

The 4.9 million here and the 153 systems in the next article occupy the same field. One is a disposable consumable and the other equipment used repeatedly. The size of the number connects neither to how many people are affected nor to how severe the harm could be.

4A big number is not heavy harm

A large quantity means a large recall operation. How many people are actually using the product is not something this field answers. Units already used and discarded and units still sitting in a warehouse both sit inside the same figure. What actually decides whether a recall concerns you is less the quantity than the fields identifying the product, the distribution and the dates.

Why it matters

The quantity field shows the scale of a recall operation, but its units vary by product, so figures are not built for direct comparison. Disposables run into millions while installed equipment stays in the tens. Neither severity nor the number of people affected can be inferred from the size of the number, which is why product identifiers, distribution and dates have to be read alongside it.

FAQ

Are all 4.9 million units defective?
The quantity is the number of units subject to recall; it does not indicate that every unit failed.
Why are the units inconsistent?
What counts as one differs by product. Disposables are counted individually while installed equipment is counted by system.
Does a larger quantity mean greater danger?
No. Quantity indicates the scale of the recall operation and is a separate field from the class, which estimates potential harm.

Related explainers

Sources (primary)

Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.

#FDA recalls#Medical devices#Quantity#Diabetes#United States

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