Z-1025-2013Class III

Dual Tip Marker, Sterile

Name: Z-1025-2013 Dual Tip Marker, Sterile
Creator: Viscot Medical LLC
Published: 2012-08-22
License: https://open.fda.gov/license/

Viscot Medical LLC / initiated 2012-08-22 / Terminated / root cause: design

FDA source

Viscot Medical LLC began a recall of 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... on 2012-08-22. FDA classified it as Class III and gives the reason as "Dual Tip Marker has inconsistent ink flow on the black permanent ink side". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1025-2013
Classification: Class III
Status: Terminated
Initiated: 2012-08-22
Posted: 2013-03-29
Terminated: 2014-07-21
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.
Product code: FZZ Marker, Skin
Reason for recall: Dual Tip Marker has inconsistent ink flow on the black permanent ink side.
Root cause tag: design
FDA 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 in commerce: 458,589 markers
Distribution: USA Nationwide Distribution
Product codes and lots: 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 #).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1025-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1025-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-10	2013-03-29

Product code FZZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)