Class 2 Device Recall Olympus

• Date Initiated by Firm: November 10, 2023
• Date Posted: January 31, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0936-2024
• Recall Event ID: 93508
• 510(K)Number: K180086
• Product Classification: Stents, drains and dilators for the biliary ducts - Product Code FGE
• Product: EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1580
• Code Information: UDI-DI: 00821925033191 Lot Numbers: 360910, 360911, 364014, 364158, 364338, 367646, 367647, 367648, 383363, 383846, 383847, 384058
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; Center Valley PA 18034-8229
• For Additional Information Contact: SAME; 484-896-5000
• Manufacturer Reason for Recall: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
• FDA Determined Cause: Process control
• Action: Olympus issued Urgent Medical Device Removal Letter on 11/10/23. Firm issued a Correction letter dated December 1, 2023 to the letter of November 10, 2023 including Additional Lot numbers . Letter states reason for recall, health risk and action to take: 1. Inspect your inventory and identify any models and lots subject to this action. Please check all areas of the hospital to determine if any of these devices remain in inventory. Quarantine and cease use of the affected model/lots. Any models and lots that are not impacted can remain in inventory and be used. The model/lot number can be found on the box or pouch in Figure 1. 2. Call your Olympus customer service representative at 1-800-848-9024, option 2, with the quantity, model, and lot number of affected devices. Olympus will issue a Return Material Authorization to return any affected product at no charge. Olympus will issue a credit to your facility upon return of affected product. 3. Access the Olympus recall portal to indicate that you have received this notification: a. Go to https://olympusamerica.com/recall. b. Enter the recall number: 0433 c. Complete the form as instructed. 4. If you have distributed these devices outside your facility, please notify your customers of this matter immediately. Your notification to your customers may be enhanced by including a copy of this letter. Olympus requests that you report complaints to our Technical Assistance Center (TAC) at 1-800-848-9024, option 1.
• Quantity in Commerce: 5232 units
• Distribution: Nationwide. Foreign: AU BR BR CA DE HK IN JP SG
• 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 = FGE