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Distal Attachment recallZ-2523-2023 · Aomori Olympus Co., Ltd. · initiated Jul 27, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Aomori Olympus Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

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 1-800-848-9024, option 2. Olympus will issue a Return Material Authorization to return any affected product at no charge to you. Olympus will issue a credit to your facility for your affected product. 3. Olympus requests that you acknowledge receipt of this letter through the Olympus recall portal. a. Go to https://olympusamerica.com/recall b. Enter the file (recall) number: 0429 4. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process. Olympus requests that you report complaints, including patient physical condition suspected to be affected by DEHP, to Olympus. Please report complaints to our Technical Assistance Center (TAC) at 1-800-848-9024 (option 1). If you require additional information, please contact Tara Safi, Field Corrective Actions Administrator at [email protected].

Recall details

Recall number
Z-2523-2023
Status
Open, Classified
Initiated by the company
Jul 27, 2023
Posted by the FDA
Sep 7, 2023
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
1,252 units
Product code
FDS
FDA submissions
K984358
Distribution
US Nationwide distribution.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

13 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 92784).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page