Approximately 22 units of TERUMO HydroPearl Compressible Microspheres for Embolisation are being recalled because the company failed to follow prescribed manufacturing and quality control processes. This product was inadvertently distributed despite these manufacturing lapses, which could compromise the quality or safety of the device. This recall specifically affects model number HP2S0600 (REF 8HP2S600) with lot number 0000342047.
Failure to adhere to strict manufacturing and quality standards can result in products that do not meet performance specifications, potentially leading to ineffective medical procedures or patient safety concerns during embolisation.
manufacturer or healthcare provider 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.
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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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