Approximately 108 million piston syringes sold under brand names including Medline, GMAX, Medigrative, and Wolf Medical (WOLF-PAK) are being recalled because they feature sizes and configurations that have not been cleared by the FDA. These non-sterile and sterile syringes, used for various medical injections and procedures, were manufactured in China and distributed nationwide, specifically in states like California, Florida, Georgia, Illinois, Tennessee, and Virginia. Consumers should verify if their specific model and lot number are included in this massive voluntary recall initiated by Jiangsu Shenli Medical Production Co., Ltd.
Using medical devices that have not been properly cleared by the FDA means their safety and performance have not been verified, which can lead to inaccurate dosing or mechanical failure during medical procedures. While no injuries are specifically detailed in this notice, the large-scale distribution of unauthorized medical equipment poses a potential risk to patient safety and treatment efficacy.
Contact healthcare provider or manufacturer
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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.