Aomori Olympus Co., Ltd. is recalling approximately 2,300 distal attachments, including those found in Olympus Disposable EMR Kits and various reusable models. These medical device components, which attach to the end of an endoscope during procedures, contain levels of di-2-ethylhexyl phthalate (DEHP) that exceed safe exposure limits set by international safety standards. Patients undergoing procedures with these devices may be exposed to higher-than-permissible levels of this chemical. Consumers and healthcare providers should check their inventory for affected lot numbers and model numbers and contact Olympus for further instructions.
The distal attachments contain the chemical DEHP at levels that exceed permissible exposure limits. This poses a potential health risk to patients as the chemical can leach from the device into the body during endoscopic procedures.
Manufacturer instructions for chemical exposure non-compliance
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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Sources: FDA iRES · Raw API Response
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