Class 2 Device Recall Olympus Distal Attachment (in Olympus Disposable EMR Kit)

• Date Initiated by Firm: July 27, 2023
• Date Posted: September 07, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2522-2023
• Recall Event ID: 92784
• 510(K)Number: K984358
• Product Classification: Gastroscope and accessories, flexible/rigid - Product Code FDS
• Product: Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope.; Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012
• Code Information: (1)K-001: Lot Numbers: 5835330 0XI, 0YI, 12I, 14I, 15I, 16I, 17I, 26K, 27K, 28K, 29K, 2XK, 2YK, 2ZK, 31K, 32K. UDI: 4953170048562 (2) K-002 Lot Numbers: 5835430 0XI, 0YI, 12I, 13I, 14I, 16I, 17I, 27K, 2XK, 2YK, 2ZK 4953170048579 K-003 5835530 0XI, 0YI, 12I, 13I, 14I, 15I, 16I, 17I, 25K, 26K, 27K, 28K, 29K, 2XK, 2YK, 2ZK UDI:4953170048586 (3)K-004 Lot Numbers: 5835630 16I, 17I, 26K UDI: 4953170048593 (4)K-011 Lot Numbers: N2485230 0XI, 15I, 17I UDI: 4953170214035 (5) K-012 Lot Numbers: N2485330 16I, 17I UDI: 4953170214042
• Recalling Firm/ Manufacturer: Aomori Olympus Co., Ltd.; 2 Chome 248-1; Okkonoki; Kuroishi Japan
• For Additional Information Contact: SAME; 172-528511
• Manufacturer 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
• FDA Determined 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 1-800-848-9024, 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 Tara.Safi@Olympus.com.
• Quantity in Commerce: 1,048 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FDS and Original Applicant = OLYMPUS AMERICA, INC.