Device recall

Z-1322-2026: Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology…

FDA device recall · Class I · Medline Industries, LP

Key facts

Recall number (Z-number) Z-1322-2026
Recall event 98277
Product Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 401227RH 401260RH 401261RH 401306RH 401309RH 401312RH 401430RH 401433RH 401435RH 401441RH 401442RH…
Product code NLH
Recalling firm Medline Industries, LP
Recall class Class I
Status Open, Classified
510(k) numbers K241156
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)