# Major Recall Alert: MOLLI 2 Tablet, MOLLI 2 Wand, MOLLI Introducer, MOLLI Marker, and MOLLI OncoPen Recalled Due to Safety Risks in IFU Instructions Update
On **June 5, 2025**, Stryker issued a critical update to the Instructions for Use (**IFU**) for their **MOLLI 2 system**, including the **MOLLI Marker**, after two medical device reports (**MDRs**) were submitted to the Food and Drug Administration (**FDA**). These reports revealed incidents of **marker dislodgement or dislocation**, likely caused by the **magnetic attraction** of nearby magnetized surgical tools during localization. The updated IFU now includes a specific warning advising healthcare professionals to avoid using magnetized tools near the marker, as doing so may cause serious patient injuries.
If you are a healthcare professional or have undergone procedures involving the MOLLI 2 system, here’s what you need to know:
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## Why This Recall is Important
This recall highlights a significant safety hazard with the use of the MOLLI 2 system. Precision is critical when localizing tissue or performing surgical procedures, and **marker dislodgement** increases the risk of complications for patients. The MDRs submitted to the FDA report patient injuries directly attributed to the system's susceptibility to **magnetic interference** from surgical tools.
## Overview of the Affected Products
The recall involves several products under the MOLLI 2 system:
- **MOLLI 2 Tablet**
- **MOLLI 2 Wand**
- **MOLLI Introducer and MOLLI Marker**
- **MOLLI OncoPen**
The MOLLI 2 system is widely used across healthcare facilities for breast cancer surgeries and tissue localization. Consequently, these updated instructions serve as an essential reminder to healthcare providers about adhering to safe practices when using medical devices in the operating room.
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### Details of the Recall
- **Date Announced:** June 5, 2025
- **Reason for Update:** Patient injuries caused by marker dislodgement/dislocation due to magnetic attraction from magnetized surgical tools.
- **Changes to IFU:**
- New warning added about **proximity of magnetized tools** during localization.
- Clearer operational guidelines to improve patient safety.
- **Source Link:** [Government of Canada Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/molli-2-systems)
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## What You Should Do
If your healthcare institution uses MOLLI 2 systems or if you’ve had a procedure involving these devices, consider the following steps to ensure safety:
1. **Healthcare Providers:**
- Review and understand the updated Instructions for Use (**IFU**) immediately.
- Train all surgical teams to avoid bringing magnetized tools into proximity with the MOLLI Marker during localization.
- Perform an audit to ensure compliance with the updated safety measures.
2. **Patients Awaiting Surgery:**
- Ask your surgical provider about the tools and systems being used during the procedure.
- Inquire whether proper precautions, as listed in the updated IFU, are being implemented.
3. **Patients Who’ve Undergone Surgery:**
- If you’ve had a surgical procedure involving a MOLLI Marker and are experiencing unusual symptoms, contact your healthcare provider promptly.
Your safety is paramount. By following these steps, you can reduce the risk of device complications and ensure proper surgical outcomes.
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## Stay Safe – Get Instant Recall Alerts
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### Stay Ahead of Safety Risks
Click [here](https://recalls-rappels.canada.ca/en/alert-recall/molli-2-systems) to view the **official recall notice** and learn more. Join thousands who trust our platform for timely updates on product recalls and safety warnings.
Your health and safety come first. Stay informed, stay safe.