Sol-Millennium Medical Inc. is recalling various SOL-M, SOL-CARE, MEDLINE, MONOJECT, and HENRY SCHEIN brand syringes and tip caps. The FDA discovered that these medical devices are substantially different from the versions originally cleared for sale, involving major changes to how the devices are intended to be used. Because these modifications were not reviewed by safety regulators, the reliability and safety of the devices cannot be guaranteed. These products were distributed across the United States and multiple international locations including Canada, the UK, and Germany.
The use of these syringes may lead to improper medical procedures or device failure because the products in distribution differ significantly from the design and intended use cleared by the FDA. While no specific injuries were mentioned, unauthorized modifications to medical injection devices pose a medium risk of patient harm or ineffective treatment.
Device use discontinuation and professional 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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