Recall Z-2523-2023 ยท FDS Gastroscope And Accessories, Flexible/Rigid
Aomori Olympus Co., Ltd.
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
| Date | Sep 7, 2023 (initiated Jul 27, 2023) |
| Status | Open, Classified |
| Reason | The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002 |
| Root cause | Nonconforming Material/Component |
| Action | Olympus issued Urgent Medical Device Recall Letter dated July 27, 2023 to ENDOSCOPY DEPARTMENT, RISK MANAGEMENT. Letter states reason for recall, health risk and action to take: Immediately assess any product you have to identify the product number with affected lot listed in this communication, cease use and quarantine any affected products. The image below depicts the area where the lot number is identified. The lot# is on the Carton box and Pack. Please refer to Attachment 2 for the identification of the subject products. 2. Call your Olympus customer service representative at 1-800-848-902 |
| Quantity | 1,252 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984358 | OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597 Olympus America, Inc., Sep 17, 1999 |