FDA Medical Device Recalls (openFDA)
Viscot Medical LLC: Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.
- Recall number
- Z-1025-2013
- Recalling firm
- Viscot Medical LLC
- Product
- Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.
- Status
- Terminated
- Initiated
- 2012-08-22
- Posted
- 2013-03-29
- Terminated
- 2014-07-21
- Reason
- Dual Tip Marker has inconsistent ink flow on the black permanent ink side.
- Root cause
- Device Design
- Action
- Viscot Medical LLC sent a Customer Notification Letter dated August 22, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to return the affected product for a replacement. To return the product call 1-800-221-0658 or e-mail jeffl@viscot .com for the RGA.
- Quantity
- 458,589 markers
- Distribution
- USA Nationwide Distribution
- Lot, serial or model codes
- Lot# 022043, 022045, 022046, 042084, 042085, 042086, 042087, 042088, 042089, 052128, 052129, 052130, 052131, 062167, 062168, 062169, 062170, 072200, 072201, 072203, 072205, 072206, 072207 (Including any letter suffixes after lot #).
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FZZ
- Firm FEI
- 2242656
- Firm city
- East Hanover
- Firm state
- NJ
- 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