DeRoyal Industries Inc is recalling 1,419 surgical procedure packs because they contain a defective Stryker SafeAir Smoke Evacuation Pencil. The pencil component in these kits has been reported to activate unexpectedly without user input or remain active even after buttons are released. The recall affects several varieties of Tracepacks, including those used for C-sections and pediatric surgeries, which were distributed to hospitals and surgical centers in Ohio.
The malfunctioning surgical pencils can activate on their own or fail to shut off, creating a significant risk of unintended tissue damage, burns to the patient or surgical staff, and potential operating room fires.
Recall #: Z-0306-2025
Recall #: Z-0307-2025
Recall #: Z-0308-2025
Recall #: Z-0309-2025
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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