Recall Z-1427-2026 ยท NEU Marker, Radiographic, Implantable
Stryker Corporation
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 i
| Date | Feb 17, 2026 (initiated Jan 21, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by 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 |
| Quantity | 5,864 |
| Distribution | 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, Panam |
| FDA record | Open on fda.gov |