Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012
Reported: September 13, 2023 Initiated: July 27, 2023 #Z-2522-2023
Product Description
Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012
Reason for Recall
The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
Details
- Recalling Firm
- Aomori Olympus Co., Ltd.
- Units Affected
- 1,048 units
- Distribution
- US Nationwide distribution.
- Location
- Kuroishi, N/A
Frequently Asked Questions
What product was recalled? ▼
Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012. Recalled by Aomori Olympus Co., Ltd.. Units affected: 1,048 units.
Why was this product recalled? ▼
The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 13, 2023. Severity: Moderate. Recall number: Z-2522-2023.
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