Hologic, Inc. is recalling 55,335 units of the Sertera Biopsy Device (Model Sertera-14) because the device's inner needle can separate from its hub. This defect can result in a longer needle throw than intended or the needle becoming dislodged during a procedure. The affected biopsy instruments were distributed nationwide to hospitals, surgical centers, and medical supply distributors.
If the needle separates during use, it could cause unintended tissue damage or leave the needle lodged inside the patient's body. No injuries or incidents have been explicitly reported in this recall notice.
Recall Number Z-1170-2025
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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