Approximately 755,800 Situate Laparotomy Sponges are being recalled because packs of five may contain an incorrect product. These incorrect sponges were not properly steam-treated to ensure sterility and are missing the Radio Frequency (RF) tags required for tracking during surgery. If used, these sponges could cause serious infections, tissue damage, or sepsis. Furthermore, because they lack the proper safety tags, automated medical scanners may incorrectly signal that no sponges remain in a patient, potentially leading to a sponge being left behind after surgery. Consumers and healthcare providers should contact their manufacturer or healthcare provider for guidance.
The incorrect sponges lack Radio Frequency (RF) tags, which prevents medical scanners from detecting them inside a patient's body. Additionally, because the product did not receive the required steam pre-treatment before sterilization, it may be non-sterile, posing a severe risk of infection and life-threatening sepsis.
Manufacturer notification and guidance
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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