FDA Medical Device Recalls (openFDA)
Medtronic: BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01
- Recall number
- Z-1472-2017
- Recalling firm
- Medtronic
- Product
- BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01
- Status
- Terminated
- Initiated
- 2017-02-08
- Posted
- 2017-02-28
- Terminated
- 2019-07-18
- Reason
- Handle may break during use.
- Root cause
- Nonconforming Material/Component
- Action
- A recall was initiated on February 8, 2017. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 1856 Corporate Dr. Suite 140 Norcross, GA 30093, Attention: Field Returns Department. Disposition of product within Medtronic control and customer returned devices: Will be reworked.
- Quantity
- 1,096 Units (total for all products)
- Distribution
- US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE
- Lot, serial or model codes
- Lot Number: B000000176, B000000181
- 510(k) numbers
- ["K103668"]
- PMA numbers
- not on file
- Product code
- FCG
- Firm FEI
- 1219930
- Firm city
- North Haven
- Firm state
- CT
- 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