CLASS II ONGOING Device recall · Reported 13 Sep 2023 · FDA Enforcement Report
Reusable distal attachments recalled by Aomori Olympus Co
Aomori Olympus is recalling Reusable distal attachments, distributed nationwide in the US. The recall was initiated on 27 Jul 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2523-2023
- FDA event ID
- 92784
- Recalling firm
- Aomori Olympus, Kuroishi, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Jul 2023
- FDA classified
- 7 Sep 2023
- Reported
- 13 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 27 Jul 2023 | Recall initiated by company | |
| 7 Sep 2023 | Classified by FDA | +42 days |
| 13 Sep 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
Which lots 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
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 92784This product is part of a recall event; the main page for the event is Olympus Distal Attachment (in Olympus Disposable EMR Kit) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Olympus Distal Attachment (in Olympus Disposable EMR Kit) recalled | Aomori Olympus | Other | Nationwide |
More recalls from Aomori Olympus
All 113| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Olympus Distal Attachment (in Olympus Disposable EMR Kit) recalled | Aomori Olympus | Other | Nationwide |
| Device | CLASS II | Na-201sx-4021 Aspiration Needle Vizishot recalled by Aomori Olympus Co | Aomori Olympus | Sterility | Nationwide |
| Device | CLASS II | Injector Forcemax Lower recalled by Aomori Olympus Co | Aomori Olympus | Sterility | Nationwide |
| Device | CLASS II | Injector Forcemax Up 2.8mmch recalled by Aomori Olympus Co | Aomori Olympus | Sterility | Nationwide |
| Device | CLASS II | Needlemaster 4MMx Upper recalled by Aomori Olympus Co | Aomori Olympus | Sterility | Nationwide |
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