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

Recall Z-1275-2023 — FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System

U.S. FDA — Device Enforcement · United States · 2023-02-13 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1275-2023
Date of alert
2023-02-13
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Abbott Diabetes Care, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
357599805005
Reported risk: Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it will no longer hold charge, or it fails Reader Test. Do not use other chargers. User Manual update includes instructions on reader safe storage, charging, use.
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.