FDA recall, , Moderate risk
Stryker MOLLI 2 System, Introducers, Wand, OncoPen and Tablet
The Molli 2 System needs updated labeling because magnetized surgical tools can dislodge markers during tissue removal.
Summary by Recall Canary from the FDA notice
What happened
Stryker Corporation, of San Jose, California, began recalling the MOLLI 2 System on January 21, 2026, because the product labeling needs updating after magnetized surgical tools dislodged markers during target tissue removal procedures. The system includes the MOLLI Introducer, MOLLI Marker, MOLLI 2 Wand, MOLLI OncoPen, and MOLLI 2 Tablet.
The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical s. The FDA added the recall to its Enforcement Report on February 17, 2026, and it was listed in the weekly enforcement report on February 25, 2026. Distribution was worldwide, including U.S. nationwide and the countries of Canada, Singapore, Panama, Jamaica, and Cayman Islands.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
MP2001 - MOLLI 2 Wand
- UDI-DI
- 00850024195141
MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker
- UDI-DI
- 00850024195028
MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker
- UDI-DI
- 00850024195134
MP2015A - MOLLI OncoPen
- UDI-DI
- 00850024195219
MT2001 - MOLLI 2 Tablet
- UDI-DI
- 00850024195158
Recall details
- Company began the recall
- Sold in
- 46 states and DC
Worldwide - U.S. Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii ID, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia, Wisconsin, and Wyoming. The countries of Canada, Singapore, Panama, Jamaica, and Cayman Islands.
- Company
- Stryker CorporationSan Jose, California
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98295
- Recall number
- Z-1427-2026
All recalls from Stryker Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
