Orise Gel Pack and Procedure Kit recall in Canada: performance issue
In plain language
This recall involves Orise Gel Pack and Procedure Kits sold in Canada. It's being recalled because of a performance issue that can lead to foreign body reactions. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Contact the manufacturer if you require additional information.
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Affected products
Orise Gel Syringe Single Pack
Model: M00519210, M00519211, M00519220, M00519221, M00519230, M00519231
Lot: All lots
Orise Gel Syringe Twin Pack
Model: M00519200, M00519201
Lot: All lots
Orise Gel Twin Syringe Kit With Interject
Model: Not applicable
Lot: All lots
Orise Proknife Procedure Kit
Model: M00519380, M00519390, M00519400
Lot: All lots
Why this matters
Performance issue leading to foreign body reaction
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: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: M00519200, M00519201, M00519210, M00519211, M00519220, M00519221, M00519230, M00519231, M00519380, M00519390, M00519400, Not applicable
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 foreign body reaction
What should consumers do?
Stop using the product immediately. Contact the manufacturer if you require 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 leading to foreign body reaction
When was this product recalled?
This product was recalled on December 30, 2022.
Is the BOSTON SCIENTIFIC CORPORATION brand affected by this recall?
Yes, BOSTON SCIENTIFIC CORPORATION products are affected by this recall. This recall involves Orise Gel Pack and Procedure Kits sold in Canada. It's being recalled because of a performance issue that can lead to foreign body reactions. Stop using the product and follow the return/repair steps in the official notice.