Medical device recall in Canada: Olympus distal cover may detach
In plain language
This recall involves the Olympus Single Use Distal Cover and EVIS EXERA III Duodenovideoscope sold in Canada. It's being recalled because the distal cover may unexpectedly detach during use. 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 for more information.
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Affected products
Single Use Distal Cover
Model: MAJ-2315
Lot: All lots
EVIS EXERA III Duodenovideoscope
Model: TJF-Q190V
Lot: All lots
Why this matters
Medical device 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: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: MAJ-2315, TJF-Q190V
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?
Medical device performance issue
What should consumers do?
Stop using the product immediately. Contact the manufacturer for more 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. Medical device performance issue
When was this product recalled?
This product was recalled on January 10, 2024.
Is the OLYMPUS MEDICAL SYSTEMS CORP. brand affected by this recall?
Yes, OLYMPUS MEDICAL SYSTEMS CORP. products are affected by this recall. This recall involves the Olympus Single Use Distal Cover and EVIS EXERA III Duodenovideoscope sold in Canada. It's being recalled because the distal cover may unexpectedly detach during use. Stop using the product and follow the return/repair steps in the official notice.