The Recall Desk
HighFDA (Devices)·Z-2523-2023·Announced 2023-09-13

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.

What this means for you

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, MAJ-
Manufacturer
Aomori Olympus Co., Ltd.
Category
Medical Device — Endoscopy / Accessories
Hazard
  • dehp
  • chemical-exposure

Distribution

Distributed nationwide across the United States.

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