Recall Z-1122-2022 ยท FBN Choledochoscope And Accessories, Flexible/Rigid
Olympus Corporation of the Americas
Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
| Date | Mar 31, 2022 |
| Status | Terminated |
| Reason | Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps |
| Root cause | 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. O |
| Quantity | 1386 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.