FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Merit Advance Angiographic Needle label reading in part: MAJESTIK SERIES ANGIOGRAPHIC NEEDLES 20 G CATALOG NUMBER AN20T52C for the introduction of vascular access devices.
- Recall number
- Z-0514-2010
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Merit Advance Angiographic Needle label reading in part: MAJESTIK SERIES ANGIOGRAPHIC NEEDLES 20 G CATALOG NUMBER AN20T52C for the introduction of vascular access devices.
- Status
- Terminated
- Initiated
- 2009-09-29
- Posted
- 2009-12-14
- Terminated
- 2009-12-15
- Reason
- Potential sterility breach caused by excessive shipment damage.
- Root cause
- Other
- Action
- Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365.
- Quantity
- 25 angiographic needles
- Distribution
- US (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution.
- Lot, serial or model codes
- Lot #F611693
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DXT
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- 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