Stryker Corporation Recalls MOLLI 2 System Components Over Marker Dislodgement Risk

What Happened

Stryker Corporation has initiated a voluntary recall of the MOLLI 2 System due to a necessary update to the product’s Instructions for Use (IFU). The recall was prompted by findings that magnetized surgical tools can dislodge markers while they are being used during target tissue removal procedures. The MOLLI Marker is designed to be placed in soft tissue to temporarily mark a surgical site for removal.

Which Products Are Affected

A total of 5,864 units are affected by this recall. The MOLLI 2 System components include:

• MOLLI Introducer (8cm, 14G) and MOLLI Marker: Catalog Number MM1000 (Pack of 10), UDI (GTIN) 00850024195028.
• MOLLI Introducer (12cm, 14G) and MOLLI Marker: Catalog Number MS-00009 (Pack of 10), UDI (GTIN) 00850024195134.
• MOLLI 2 Wand: Catalog Number MP2001, UDI (GTIN) 00850024195141.
• MOLLI OncoPen: Catalog Number MP2015A, UDI (GTIN) 00850024195219.
• MOLLI 2 Tablet: Catalog Number MT2001, UDI (GTIN) 00850024195158.

Distribution was worldwide, including nationwide across 47 U.S. states and the District of Columbia, as well as Canada, Singapore, Panama, Jamaica, and the Cayman Islands.

What You Should Do

Stryker Corporation initiated the recall by sending notification letters to affected customers starting January 21, 2026. Healthcare providers and facilities using the MOLLI 2 System should review the updated Instructions for Use (IFU) provided by the firm to ensure surgical tools do not inadvertently dislodge markers during procedures.

Why This Matters

This recall is significant because the unintended movement or dislodgement of a surgical marker during tissue removal could lead to inaccuracies during surgery or the failure to remove the intended target tissue. The FDA has classified this as a Class II recall.

Source

Recall information provided by the FDA under Recall Number Z-1427-2026.