Reported Sep 13, 2023 · Ongoing
Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope.…
Aomori Olympus Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aomori Olympus Co., Ltd. · 2 Chome 248-1 · Kuroishi, N/A · N/A
Is this the product you have?
- Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope
- Disposable EMR Kit
K-001K-002K-003K-004K-011K-012
- Lot codes and dates
5 of 5 products
Products covered by this recall # Barcodes Product as published 1 4953170048562Lot Numbers: 5835330 0XI, 0YI, 12I, 14I, 15I, 16I, 17I, 26K, 27K, 28K, 29K, 2XK, 2YK, 2ZK, 31K, 32K. UDI: 4953170048562 (2) K-002 2 49531700485794953170048586Lot Numbers: 5835430 0XI, 0YI, 12I, 13I, 14I, 16I, 17I, 27K, 2XK, 2YK, 2ZK 4953170048579 K-003 5835530 0XI, 0YI, 12I, 13I, 14I, 15I, 16I, 17I, 25K, 26K, 27K, 28K, 29K, 2XK, 2YK, 2ZK UDI:4953170048586 (3)K-004 3 4953170048593Lot Numbers: 5835630 16I, 17I, 26K UDI: 4953170048593 (4)K-011 4 4953170214035Lot Numbers: N2485230 0XI, 15I, 17I UDI: 4953170214035 (5) K-012 5 4953170214042Lot Numbers: N2485330 16I, 17I UDI: 4953170214042 - Amount recalled
- 1,048 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Aomori Olympus Co., Ltd. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.