FDA Medical Device Recalls (openFDA)
Olympus America Inc.: OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.
- Recall number
- Z-0029-2012
- Recalling firm
- Olympus America Inc.
- Product
- OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.
- Status
- Terminated
- Initiated
- 2011-08-25
- Posted
- 2011-10-07
- Terminated
- 2012-09-28
- Reason
- Firm has received complaints from users of the ability to wipe material from the needle's stylet and the presence of material in patient cytology samples obtained by the needle following endobronchial ultrasound fine needle aspiration of a lesion. Olympus Medical Systems Corporation (OMSC) in Japan has confirmed that metal particles can occur on the stylet due to friction between the stylet and n
- Root cause
- Device Design
- Action
- OLYMPUS sent an URGENT MEDICAL DEVICE CORRECTION letter dated August 26, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A revised Instruction Manual with the new WARNINGS will be sent to the customer's attention. Customers were instructed to examine their inventory to determine if they have the affected product. To share the information on the new WARNINGS with all of the appropriate staff at their facility and any other organization where the product has been transferred. Complete and return the enclosed questionnaire even if they do not have affected product. Customers were instructed to fax the completed questionnaire to 484-896-7128. For any question call 484-896-5688.
- Quantity
- 22,498
- Distribution
- Nationwide Distribution including the District of Columbia and the following States: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.
- Lot, serial or model codes
- Models: NA-201SX-4022-A --22 gauge needle: all lot numbers; NA-201SX-4022-B --22 gauge needle: all lot numbers; NA-201SX-4022-C --22 gauge needle: all lot numbers; and NA-201SX-4021 -- 21 gauge needle: all lot numbers.
- 510(k) numbers
- ["K050503"]
- PMA numbers
- not on file
- Product code
- FCG
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28