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

MOLLI 2 System Recall Summary Stryker Corporation is recalling the MOLLI 2 System, which includes introducers, markers, a wand, pen, and tablet used to mark surgical sites for tissue removal. The recall was issued because magnetized surgical tools can dislodge the markers during removal procedures, requiring updated instructions for use. This is a Class II recall affecting the MM1000, MS-00009, MP2001, MP2015A, and MT2001 products.

Recalling firm: Stryker Corporation
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 (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.
Reason: Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.
Classification: Class II
Category: consumer product recall
Country: United States
Agency: FDA-DEVICES
Recall date: 2026-01-21
Status: Open, Classified

Recall details on Nibble Recalls: https://trynibble.app/recalls/d3f0fe1f-0f32-44b3-aee5-206ec9b0bc7b