Z-1616-2023Class III

To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and...

Name: Z-1616-2023 To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and...
Creator: Olympus Corporation of the Americas
Published: 2023-03-31
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-03-31 / Open, Classified / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and... on 2023-03-31. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1616-2023
Classification: Class III
Status: Open, Classified
Initiated: 2023-03-31
Posted: 2023-05-19
Recalling firm: OLYMPUS Corporation of the Americas
Product: 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 Models: NA-U401SX-4022, NA-U401SX-4022-A
Product code: FCG Biopsy Needle
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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
Quantity in commerce: 1297 (Boxes; 5 per Box)
Distribution: Natiowide Foreign: Canada, Germany
Product codes and lots: UDI: 04953170388286 Lot numbers: KR248740 KR248746 KR252863 KR253666 KR253681 KR260854 KR260865 KR260873 KR260875 KR260876 KR260877 KR260896 KR260917 KR260937

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1616-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1615-2023	Class III	Ongoing	Voluntary: Firm initiated	2023-05-31	2023-05-19
Z-1616-2023	Class III	Ongoing	Voluntary: Firm initiated	2023-05-31	2023-05-19

Product code FCG

K160098Class IISingle Use Aspiration Needle NA-U401SXOlympus Medical Systems Corp. / cleared 2016-03-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)