Reusable distal attachments recall
Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593…
Why was Reusable distal attachments 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?
Model: UDI: MH-462 4953170047732 MH-463 4953170047756 MH-464 4953170047770 MH-465 4953170047794 MH-466 4953170047817 MH-483 N/A MH-587 4953170047855 MH-588 4953170364518 (US) MH-589 4953170047893 MH-590 N/A MH-591 4953170047930 MH-592 N/A MH-593 4953170047978 MH-594 4953170047992 MH-595 4953170048012 MH-596 N/A MH-597 4953170048050 MH-598 N/A MAJ-289 N/A MAJ-290 N/A MAJ-291 N/A MAJ-292 N/A MAJ-293 N/A MAJ-294 N/A MAJ-295 N/A MAJ-296 N/A MAJ-297 N/A MAJ-663 N/A MAJ-664 N/A MAJ-665 N/A MAJ-666 N/A DIstal Attachment- All lots
- Product
- Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593…
- Recalling firm
- Aomori Olympus Co., Ltd.
- Quantity
- 1,252 units
- Distribution
- US Nationwide distribution.
- Recall date
- September 13, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)