Single Use Guide Sheath Kit recall in Canada: performance issue
In plain language
This recall involves the Single Use Guide Sheath Kit from Olympus Medical Systems Corp. sold in Canada. It's being recalled because the radiopaque tip of the guide sheath component may detach during use. This could lead to serious injuries if the tip falls off into the patient. This recall is for healthcare professionals.
What to do
- Contact the manufacturer if you require additional information.
- Follow the Instructions For Use (IFU) for the Single Use Guide Sheath Kits.
- Pay close attention to inspection directions and warnings about not forcing instruments.
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Affected products
Single Use Guide Sheath Kit
Model: K-201, K-202, K-203, K-204
Lot: All lots
Why this matters
Internal injury risk from detached medical device component
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: K-201, K-202, K-203, K-204
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?
Internal injury risk from detached medical device component
What should consumers do?
Contact the manufacturer if you require additional information. Follow the Instructions For Use (IFU) for the Single Use Guide Sheath Kits. Pay close attention to inspection directions and warnings about not forcing instruments.
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. Internal injury risk from detached medical device component
When was this product recalled?
This product was recalled on January 23, 2025.
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 Single Use Guide Sheath Kit from Olympus Medical Systems Corp. sold in Canada. It's being recalled because the radiopaque tip of the guide sheath component may detach during use. This could lead to serious injuries if the tip falls off into the patient. This recall is for healthcare professionals.