Health product recall

Olympus Distal Attachment and Disposable EMR Kit

Last updated

Summary

Product
Olympus Distal Attachment and Disposable EMR Kit
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Distal Attachment All lots. MAJ-296 MH-598 MH-464 MH-593 MH-463 MH-592 MH-595 MAJ-292 MAJ-295 MAJ-297 MH-587 MH-591 MAJ-289 MAJ-293 MAJ-294 MH-462 MH-590 MH-597 MAJ-290 MAJ-291 MH-466 MH-483 MH-596
Disposable Emr Kit More than 10 numbers, contact manufacturer. K-011 K-001 K-002 K-012 K-003 K-004

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology & Urology
Companies
Olympus Medical Systems Corp.
2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74217