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Open, Classified

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.

FDA Recall Z-1427-2026 · Posted 2026-02-17

Recalling FirmStryker Corporation
Recall StatusOpen, Classified
Product CodeNEU
Date Initiated2026-01-21
Product Quantity5,864

Reason for Recall

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.

Firm Action

On 01/21/2026, the firm sent via USPS certified mail an "URGENT: Medical Device Recall" Letter to customers informing them that Stryker has updated the MOLLI 2 System Instructions for Use (IFU) following two Medical Device Reports (MDRs) submitted to the FDA. These reports involved patient injuries associated with MOLLI marker dislodgement or dislocation due to magnetic attraction from magnetized surgical tools. The updated IFU now includes an additional warning that using magnetized surgical tools in close proximity to the marker during localization may lead to marker dislodgement. Customers are instructed to: 1. Inform individuals within their organization who need to be aware of this warning statement. 2. Review Attachment A regarding the warning statement that will be added to the IFU. Stryker estimates the updated IFUs to be released by 28FEB2026. No product return is required. 3. Complete Attachment B, Business Reply Form (page 4), as an acknowledgement of this notice and return the completed form via email to [email protected]. Response is required. 4. If customers have further distributed product, complete the table in Attachment B, Business Reply Form (page 4) and return the completed form via email to [email protected]. 5. Maintain awareness of this communication internally. For questions - contact [email protected] or Stryker Customer Service at 800-624-4422.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide - U.S. Nationwide distribution including in the states of AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY. The countries of Canada, Singapore, Panama, Jamaica, and Cayman Islands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K253888MOLLI 2 SystemStryker Endoscopy · 2025-12-31K231579MOLLI 2Molli Surgical, Inc. · 2023-10-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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