Olympus Corporation of the Americas ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI: 04953170388248 Lot numbers: KR243729 KR248648 KR248652 KR248673 KR248784 KR248785 KR248808 KR249160 KR251593 KR257313 KR257314 KR264662 KR264697 KR264708 KR264711 KR264726 KR264732 KR264746 KR264751 KR264778 KR264806 KR276770
Olympus Corporation of the Americas is recalling ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound g due to Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
Recommended Action
Per FDA guidance
Olympus issued Urgent Medical Medical Device Recall letter on 3/31/23 to Endoscopy Department, Pulmonology Department; Risk Management. . Letter states reason for recall, health risk and action to take: 1. Immediately locate any affected products listed in this communication and quarantine these products. 2. Contact our Olympus Customer Service Team 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 upon return of affected product. 3. Olympus requests that you acknowledge receipt of this letter through the Olympus recall portal. " Go to https://olympusamerica.com/recall and enter the recall number 0422 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, including patient injuries and adverse events, to Olympus. Please report complaints to our Technical Assistance Center (TAC) at 1-800-848-9024, option 1, to report complaints
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026