# Major Recall Alert: Ensemble Lap Chole Recalled Due to Unlicensed Ligating Clip in Canada
Medline Industries, LP, has issued a recall on its Ensemble Lap Chole packs due to an unlicensed ligating clip included in the product for use in Canada. While the substitute clip is approved and licensed for use in the United States, it has not undergone the required regulatory review by Health Canada. This discrepancy raises safety concerns and highlights the importance of ensuring medical devices meet the regulatory standards of the country in which they are used.
The recall began on **July 23, 2025**, and affects healthcare providers and patients relying on the Ensemble Lap Chole product in Canada.
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## Why This Recall is Important
This recall emphasizes the critical role that licensed medical equipment plays in patient safety and compliance with national health regulations. While the substituted ligating clip is approved for use in the U.S., it is not licensed in Canada, meaning Health Canada has not reviewed or approved its safety, efficacy, or compliance.
The potential risks associated with using an unapproved device include:
- Incompatibility with Canadian medical settings or protocols
- Potential risks to patient health and safety
This situation highlights the gaps that can arise from cross-border product substitutions and underscores the importance of vigilance in regulatory compliance.
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### Details of the Recall
Here are the key facts you need to know about this recall:
- **Product Name**: Ensemble Lap Chole
- **Brand**: Medline Industries, LP
- **Reason for Recall**: Substitution of the licensed ligating clip with an unlicensed version not reviewed by Health Canada
- **Recall Start Date**: July 23, 2025
- **Regulatory Status**: The substitute clip is licensed for use in the U.S. but not in Canada.
For full transparency and updates, refer to the official recall notice by Health Canada [here](https://recalls-rappels.canada.ca/en/alert-recall/ensemble-lap-chole).
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### What You Should Do
If you’ve purchased or used the Ensemble Lap Chole product, here’s what you need to do immediately to safeguard your health or your practice:
1. **Stop Using the Product**: Immediately halt the use of the Ensemble Lap Chole packs until further notice.
2. **Contact Medline Industries, LP**: Reach out to the manufacturer for guidance on returning the product or replacing it with a fully licensed alternative.
3. **Consult Healthcare Providers**: If you or your patients have been impacted, consult with a healthcare professional immediately.
4. **Report Adverse Reactions**: Submit any health-related incidents linked to this product to Health Canada via the [Canada Vigilance Program](https://recalls-rappels.canada.ca).
Staying proactive is crucial when health and safety are at stake.
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For further updates and details about the Ensemble Lap Chole recall, visit Health Canada's official recall notice [here](https://recalls-rappels.canada.ca/en/alert-recall/ensemble-lap-chole).
Your safety is our priority – stay informed, act quickly, and stay safe!