LMA StoneBreaker System recall in Canada: Sterilization risk
In plain language
This recall involves the LMA StoneBreaker Intracorporeal Lithotripter System and StoneBreaker System - Pneumatic Lithotripter sold in Canada. It's being recalled because the devices may not be properly sterilized when following the provided instructions. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model numbers: SBA-EC, SBA-EL, SBA-PC, SBA-SC, SBC-10, SBL-KIT1, SBP-010500, SBP-010605, SBP-016500, SBP-016605, SBP-020425.
- Return, repair, or dispose of it as instructed.
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Affected products
LMA StoneBreaker Intracorporeal Lithotripter System - Main Unit
Model: SBA-EC, SBA-EL, SBA-PC, SBA-SC, SBC-10, SBL-KIT1, SBP-010500, SBP-010605, SBP-016500, SBP-016605, SBP-020425
Lot: All lots
StoneBreaker System - Pneumatic Lithotripter
Model: SBA-EC, SBA-EL, SBA-PC, SBA-SC, SBC-10, SBL-KIT1, SBP-010500, SBP-010605, SBP-016500, SBP-016605, SBP-020425
Lot: All lots
Why this matters
Sterilization risk
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: SBA-EC, SBA-EL, SBA-PC, SBA-SC, SBC-10, SBL-KIT1, SBP-010500, SBP-010605, SBP-016500, SBP-016605, SBP-020425
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?
Sterilization risk
What should consumers do?
Stop using the product immediately. Check model numbers: SBA-EC, SBA-EL, SBA-PC, SBA-SC, SBC-10, SBL-KIT1, SBP-010500, SBP-010605, SBP-016500, SBP-016605, SBP-020425. Return, repair, or dispose of it as instructed.
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. Sterilization risk
When was this product recalled?
This product was recalled on May 1, 2018.
Is the LMA StoneBreaker brand affected by this recall?
Yes, LMA StoneBreaker products are affected by this recall. This recall involves the LMA StoneBreaker Intracorporeal Lithotripter System and StoneBreaker System - Pneumatic Lithotripter sold in Canada. It's being recalled because the devices may not be properly sterilized when following the provided instructions. Stop using the product and follow the return/repair steps in the official notice.