Olympus Distal Attachment recall
Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001…
Why was Olympus Distal Attachment recalled?
The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
(1)K-001: Lot Numbers: 5835330 0XI, 0YI, 12I, 14I, 15I, 16I, 17I, 26K, 27K, 28K, 29K, 2XK, 2YK, 2ZK, 31K, 32K. UDI: 4953170048562 (2) K-002 Lot 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 Lot Numbers: 5835630 16I, 17I, 26K UDI: 4953170048593 (4)K-011 Lot Numbers: N2485230 0XI, 15I, 17I UDI: 4953170214035 (5) K-012 Lot Numbers: N2485330 16I, 17I UDI: 4953170214042
- Product
- Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001…
- Recalling firm
- Aomori Olympus Co., Ltd.
- Quantity
- 1,048 units
- Distribution
- US Nationwide distribution.
- Recall date
- September 13, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)