Stryker MOLLI 2 System Recall: Update labeling needed for surgical markers
Stryker recalls MOLLI 2 System surgical tools due to outdated labeling that may affect marker placement during procedures. Affected units include specific model numbers and serial ranges.
Lower-risk 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.
Contact the company
What happened, in plain English
Stryker is recalling certain MOLLI 2 System surgical tools because the product labeling needs updating. This update is required to prevent magnetized surgical markers from dislodging during tissue removal procedures. Read more at govinfonow.com/recall/50121-stryker-molli-2-system-recall-update-labeling-needed-for-surgical.
Source Summary by GovInfoNow · govinfonow.com/recall/50121-stryker-molli-2-system-recall-update-labeling-needed-for-surgical · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1427-2026
Cite this page
“Stryker MOLLI 2 System Recall: Update labeling needed for surgical markers.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50121-stryker-molli-2-system-recall-update-labeling-needed-for-surgical. Based on FDA recall #Z-1427-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1427-2026%22&limit=1).
Why it’s dangerous
The magnetized surgical markers in the MOLLI 2 System may dislodge during target tissue removal procedures if the product labeling is outdated. This could lead to inaccurate surgical site marking.
Who’s affected
Medical professionals using the MOLLI 2 System for surgical procedures are likely affected. The risk is low as the issue relates to labeling updates rather than immediate safety hazards.
How to tell if you have this one
Check for the MOLLI 2 System with specific model numbers: MM1000 (Pack of 10), MS-00009 (Pack of 10), MP2001, MP2015A, and MT2001. Look for the provided serial number ranges in the recall notice.
- Brand
Stryker- Category
Medical device
What to do — step by step
Check Product Labeling
Verify if your MOLLI 2 System has the updated labeling as required by the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 46 states.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, 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, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 35 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using this product?
No, the recall requires updating the labeling, not stopping use. The product can continue to be used with the updated instructions.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1427-2026 (January 21, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1427-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.