Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Olympus DISPOSABLE GRASPING FORCEPS, FG-51D

FDA Recall Z-1122-2022 · Posted None

Recall StatusTerminated
Product CodeFBN
Date Initiated2022-03-31
Date Terminated2024-07-25
Product Quantity1386 units

Reason for Recall

Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps

Firm 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 [email protected].

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑