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

Recall Z-0154-2023 — 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM U100, mmol/L PT-000030: Assembly, DASH PDM, Canada Remote Controller (Personal Diabetes Manager or PDM) associated with Insulin Pump (Pod) *The part

U.S. FDA — Device Enforcement · United States · 2022-10-17 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0154-2023
Date of alert: 2022-10-17
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Insulet Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10385082000009

Reported risk: The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The firm has received a complaint alleging fire as a result of thermal energy from a DASH PDM.

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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