Reported Sep 13, 2023 · Ongoing

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,…

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?

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
- MH-594
- MH-595
- MH-596
- MH-597
- MH-598
- MAJ-289
- MAJ-290
- MAJ-291
- MAJ-292
- MAJ-293
- MAJ-294
- MAJ-295
- MAJ-296
- MAJ-297
- MAJ-663
- MAJ-664
- MAJ-665
- MAJ-666

Lot codes and dates: ModelUDI:
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
Amount recalled: 1,252 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to…

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.

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