Device recall

Z-1797-2026: Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7

FDA device recall · Class I · Insulet Corporation

Key facts

Recall number (Z-number) Z-1797-2026
Recall event 98586
Product Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
Product code QFG
Recalling firm Insulet Corporation
Recall class Class I
Status Open, Classified
510(k) numbers K231826
FEI number 3014585508

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)