MOSAIQ recall in Canada: Medical device performance issue
In plain language
This recall involves MOSAIQ medical devices sold in Canada. It's being recalled because of a performance issue where medication doses may not be administered. Healthcare professionals should follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model and serial numbers.
- Follow instructions for field safety notice and modification.
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Affected products
MOSAIQ 3.2.1
Model: (01)07340201500071(10)3.2.1.0, (01)07340201500071(10)3.2.1.1, (01)07340201500071(10)3.2.1.2, (01)07340201500071(10)3.2.1.3, (01)07340201500071(10)3.2.1.4
Lot: 3.2.1.0, 3.2.1.1, 3.2.1.2, 3.2.1.3, 3.2.1.4
MOSAIQ 3.1.3
Model: (01)07340201500026(10)3.1.3., (01)07340201500026(10)3.1.3.1, (01)07340201500026(10)3.1.3.2, (01)07340201500026(10)3.1.3.3, (01)07340201500026(10)3.1.3.4
Lot: 3.1.3.0, 3.1.3.1, 3.1.3.2, 3.1.3.3, 3.1.3.4
MOSAIQ 3.2.2
Model: (01)07340201500071(10)3.2.2.0, (01)07340201500071(10)3.2.2.1
Lot: 3.2.2.0, 3.2.2.1
MOSAIQ 3.2.3.0
Model: (01)07340201500071(10)3.2.3.0
Lot: 3.2.3.0
Why this matters
Performance issue leading to unadministered medication doses
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: 3.1.3.0, 3.1.3.1, 3.1.3.2, 3.1.3.3, 3.1.3.4, 3.2.1.0, 3.2.1.1, 3.2.1.2, 3.2.1.3, 3.2.1.4, 3.2.2.0, 3.2.2.1, 3.2.3.0
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: (01)07340201500026(10)3.1.3., (01)07340201500026(10)3.1.3.1, (01)07340201500026(10)3.1.3.2, (01)07340201500026(10)3.1.3.3, (01)07340201500026(10)3.1.3.4, (01)07340201500071(10)3.2.1.0, (01)07340201500071(10)3.2.1.1, (01)07340201500071(10)3.2.1.2, (01)07340201500071(10)3.2.1.3, (01)07340201500071(10)3.2.1.4, (01)07340201500071(10)3.2.2.0, (01)07340201500071(10)3.2.2.1, (01)07340201500071(10)3.2.3.0
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 leading to unadministered medication doses
What should consumers do?
Stop using the product immediately. Check model and serial numbers. Follow instructions for field safety notice and modification.
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 leading to unadministered medication doses
When was this product recalled?
This product was recalled on September 4, 2025.
Is the MOSAIQ brand affected by this recall?
Yes, MOSAIQ products are affected by this recall. This recall involves MOSAIQ medical devices sold in Canada. It's being recalled because of a performance issue where medication doses may not be administered. Healthcare professionals should follow the return/repair steps in the official notice.