Device recall

Z-1427-2026: MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm…

FDA device recall · Class II · Stryker Corporation

Key facts

Recall number (Z-number) Z-1427-2026
Recall event 98295
Product MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI…
Product code NEU
Recalling firm Stryker Corporation
Recall class Class II
Status Open, Classified
510(k) numbers K231579
FEI number 2936485

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)