Device recall

Z-1516-2024: EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition…

FDA device recall · Class II · Boston Scientific Corporation

Key facts

Recall number (Z-number) Z-1516-2024
Recall event 94165
Product EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00568211
Product code KNT
Recalling firm Boston Scientific Corporation
Recall class Class II
Status Open, Classified
510(k) numbers K031538
FEI number 3005099803

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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)