Olympus Distal Attachment and Disposable EMR Kit

Devices contain di-2-ethylhexyl phthalate (DEHP). Olympus has previously announced on the labeling that the product contains DEHP.

Since Olympus has confirmed that alternative products can be provided, Olympus has decided to ask customers to cease using the subject products and to further remove them.

In general, potential patient harms associated with the use of plastic products containing DEHP include:

chemical exposure, hypersensitivity/allergic reaction, endocrine disruption, reproductive and

developmental toxicity and carcinogenicity. Long term DEHP toxicity may occur if a distal attachment

inadvertently becomes a retained foreign body with resultant leaching over time. Olympus has not

received any reports of these harms occurring from the use of our products.

Recall start date: August 17, 2023