US FDA says J&J's Ethicon issues correction related to surgical stapler

Reuters
2025.07.25 15:39
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The U.S. FDA announced that Ethicon, a Johnson & Johnson unit, issued a serious correction for certain lots of its surgical stapler component due to a malfunction that can lead to life-threatening situations. The device, used to cut and close tissue, may fail during surgery, resulting in one reported death and one injury. Ethicon has informed affected customers but has not initiated a full product recall. Healthcare facilities are advised to review the affected batches and ensure staff are familiar with the device's usage instructions.