Covidien, LP has recalled 774,229 units of several models of Auto Suture Structural Balloon and Blunt Tip Trocars because the trocar seal may become disengaged if mesh products are used incorrectly with the device. This recall affects various models including the OMS-T10SB, OMS-T10BTNL, OMS-T10BTSNL, OMS-T12BT, OMS-T10BTS, OMS-T10BT, and OMS-T12BTNL. Consumers should be aware that this defect can compromise the surgical environment and lead to medical complications during procedures. These devices were distributed worldwide between late 2020 and early 2024.
The trocar seal can detach or disengage during surgery if mesh is inserted or used improperly. This failure can result in a loss of surgical pressure (pneumoperitoneum), potentially delaying the procedure or requiring additional medical intervention to correct the seal or the patient's condition.
Medical Device Discontinuation and Consultation
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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