Device recall

Z-1460-2025: Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters…

FDA device recall · Class II · MEDLINE INDUSTRIES, LP - Northfield

Key facts

Recall number (Z-number) Z-1460-2025
Recall event 96368
Product Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
Product code NLH
Recalling firm MEDLINE INDUSTRIES, LP - Northfield
Recall class Class II
Status Open, Classified
510(k) numbers K221067
FEI number 1417592

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)