Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0591-2024 — Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193). Used to control an

U.S. FDA — Device Enforcement · United States · 2023-11-30 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0591-2024
Date of alert: 2023-11-30
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Insulet Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 1038508112030

Reported risk: The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recognize the error on the bolus calculator screen or the confirmation screen prior to starting the bolus.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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