Stryker Sustainability Solutions is recalling 22,476 units of reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology (9 cm length). These surgical instruments may become stuck in the "on position" during use, causing them to activate continuously without user input. This issue is caused by a manufacturing defect in the reprocessed devices.
If the shears remain continuously active, they could cause unintended tissue damage or thermal burns to patients during surgery, or potentially injure surgical staff. Continuous activation may also cause the device to overheat.
Manufacturer initiated recall for clinical/hospital devices.
Quantity: 22,476 units affected.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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