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

Class I - Dangerous

🏥 Medical Devices Recalled: March 31, 2023 Olympus Corporation of the Americas Diagnostic Equipment

What Should You Do?

Check if you have this product:
UDI: 04953170388286 Lot numbers: KR248740 KR248746 KR252863 KR253666 KR253681 KR260854 KR260865 KR260873 KR260875 KR260876 KR260877 KR260896 KR260917 KR260937
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Olympus Corporation of the Americas
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

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 Codes/Lot Numbers:

UDI: 04953170388286 Lot numbers: KR248740 KR248746 KR252863 KR253666 KR253681 KR260854 KR260865 KR260873 KR260875 KR260876 KR260877 KR260896 KR260917 KR260937