Merit medical devices recall in Canada: Performance issue
In plain language
This recall involves Merit basixCOMPAK™, PhD™ Hemostasis Valve, and basixSKY™ Inflation Syringe sold in Canada. They are being recalled because a manufacturing defect may affect their performance. Stop using the product and contact the manufacturer for more information.
What to do
- Stop using the product immediately.
- Check the model and lot numbers if you have these products.
- Contact Merit Medical Systems Inc. for additional information.
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Affected products
basixCOMPAK™
Model: IN4802
Lot: I3161210, I3161211
PhD™ Hemostasis Valve
Model: MAP800, MAP801, MAP802
Lot: I3129725, I3129726, I3146099, I3186946, I3186951, I3191334, I3192937, I3206933, I3209935, I3215925, I3215926, I3219783, I3219784, I3219792
Custom Procedure Kit - Stroke Kit
Model: K12T-10798A
Lot: T3163727, T3217266
basixSKY™ Inflation Syringe
Model: SKY1802
Lot: H3079946, H3141576, H3141577, H3155575, H3155576, H3155577
Why this matters
Performance issue
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: H3079946, H3141576, H3141577, H3155575, H3155576, H3155577, I3129725, I3129726, I3146099, I3161210, I3161211, I3186946, I3186951, I3191334, I3192937, I3206933, I3209935, I3215925, I3215926, I3219783, I3219784, I3219792, T3163727, T3217266
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: IN4802, K12T-10798A, MAP800, MAP801, MAP802, SKY1802
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Performance issue
What should consumers do?
Stop using the product immediately. Check the model and lot numbers if you have these products. Contact Merit Medical Systems Inc. for additional information.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Performance issue
When was this product recalled?
This product was recalled on August 14, 2025.
Is the Merit Medical Systems Inc. brand affected by this recall?
Yes, Merit Medical Systems Inc. products are affected by this recall. This recall involves Merit basixCOMPAK™, PhD™ Hemostasis Valve, and basixSKY™ Inflation Syringe sold in Canada. They are being recalled because a manufacturing defect may affect their performance. Stop using the product and contact the manufacturer for more information.