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FDA-Device2026-02-25Class IIMISBRANDING

Stryker MOLLI 2 surgical marker system recalled for labeling update on magnetic tool interaction

Stryker
FALSE CLAIMSNationwide distribution

Check your Stryker MOLLI 2 system serial number

Stryker is recalling certain MOLLI 2 surgical marker systems because the instructions for use need to be updated. Magnetized surgical tools used during the procedure may dislodge the markers that are placed to mark the surgical site. Stryker is providing updated labeling to address this issue.

  • Locate the serial number on your MOLLI 2 system components (Introducer, Wand, OncoPen, or Tablet)
  • Check if your serial number matches the affected list provided by Stryker
  • Contact Stryker for updated instructions for use before using affected devices
  • Review new labeling guidance on proper handling to prevent marker dislodgement during surgery
Hazard

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.

Sold states
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.
Affected count
5,864
Manufactured in
5900 Optical Ct, San Jose, CA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1427-2026

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