Reusable Endoscopy Distal Attachments Recalled for Excessive DEHP Levels
Aomori Olympus recalls 1,252 reusable distal attachment devices with DEHP chemical levels exceeding safe exposure limits per medical device standards. Devices distributed nationwide in the United States.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This medical device recall is FDA Class II with no reported injuries or illnesses mentioned. The hazard—DEHP chemical exposure exceeding safe levels—represents a risk of harm but has not resulted in confirmed patient injury. Per the severity rubric, this qualifies as 'High' (Score 3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Aomori Olympus Co., Ltd. is recalling 1,252 reusable distal attachment devices in various models distributed nationwide in the United States. These attachments are components used in endoscopic medical procedures.
The recall was issued because these devices contain di-2-ethylhexyl phthalate (DEHP) exceeding the permissible exposure limit established by ISO 10993-17:2002. This international standard specifies safe levels of chemical exposure for medical devices during clinical use. The detected DEHP levels exceed these safety thresholds.
Healthcare facilities and practitioners who have received or used these recalled devices should immediately discontinue use. Facilities should contact Aomori Olympus Co., Ltd. for information regarding device replacement or proper return procedures.
The recalled product
- 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, 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…
- Manufacturer
- Aomori Olympus Co., Ltd.
- Hazard
- Affected units
- 1,252
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Aomori Olympus Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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