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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus

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  Class 2 Device Recall Olympus see related information
Date Initiated by Firm March 31, 2022
Create Date May 20, 2022
Recall Status1 Open3, Classified
Recall Number Z-1122-2022
Recall Event ID 90009
Product Classification Choledochoscope and accessories, flexible/rigid - Product Code FBN
Product Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
Code Information Lot numbers since January 2017. Affected Lot Numbers: 01K 02K 03K 04K 05K 06K 07K 08K 09K 0XK 0YK 0ZK 11H 11K 12K 13K 14K 15K 16K 17K 18K 19K 1XK 71K 72K 73K 74K 75K 76K 77H 77K 78K 79K 7XK 7YK 7ZK 81K 82K 83K 84K 85K 86K 87K 88K 89K 8XK 8YK 8ZK 91K 92K 93K 94K 95K 96K 97K 98K 99K 9XK 9YK 9ZK
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		 Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Olympus issued "URGENT: MEDICAL DEVICE RECALL" letter on March 28, 2022. Letter states reason for recall, health risk and action to take: 1. Immediately assess any product you have in stock to identify FG-51D forceps with affected lot numbers listed in this communication, cease use of product and quarantine any affected product. The image below depicts the area on the label where the lot number is identified. 2. Call your Olympus customer service representative at 1-888-524-7266 option 1. 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. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number 0407 and provide your contact information as indicated in the portal. 4. If you have distributed these devices outside your facility, please notify your customers of this corrective action immediately. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please do not hesitate to contact your Corrective Actions Lead, Americas directly at 647-999-3203 or at Cynthia.Ow@Olympus.com.
Quantity in Commerce 1386 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.
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