Medical device recall in Canada: Ball Coarse, Interproximal Fine, Alpen SteriX
In plain language
This recall involves Ball Coarse, Interproximal Fine, and Alpen SteriX medical devices sold in Canada. They are being recalled because the sterile packaging seal may be faulty. This could lead to a breach in sterility, posing a health risk. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check the lot or model numbers if you have these products.
- Return the product as instructed by the manufacturer or retailer.
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Affected products
Ball Coarse
Model: X801C018
Lot: J64631
Interproximal Fine
Model: X392F016
Lot: J64640
Alpen SteriX RC 557 FG 50pk and SS 10pk
Model: RS100557B, RS300557
Lot: J63631, J69090
Why this matters
Potential breach in sterile packaging
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: J63631, J69090, J64631, J64640
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: RS100557B, RS300557, X392F016, X801C018
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?
Potential breach in sterile packaging
What should consumers do?
Stop using the product immediately. Check the lot or model numbers if you have these products. Return the product as instructed by the manufacturer or retailer.
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. Potential breach in sterile packaging
When was this product recalled?
This product was recalled on January 10, 2020.