Device recall

Z-1021-2026: FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The…

FDA device recall · Class I · Abbott Diabetes Care, Inc.

Key facts

Recall number (Z-number) Z-1021-2026
Recall event 98049
Product FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Product code QLG
Recalling firm Abbott Diabetes Care, Inc.
Recall class Class I
Status Open, Classified
510(k) numbers K233537
FEI number 3002803444

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)