RegWardenFDA facility compliance records
Recall

Class III — Viscot Medical LLC

Recalling firmVISCOT MEDICAL LLC
Registered facilityVISCOT MEDICAL LLC (the firm's only registered facility)
ClassificationClass III
StatusTerminated
ReasonDual Tip Marker has inconsistent ink flow on the black permanent ink side.
ProductDual 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.
Quantity458,589 markers
DistributionUSA Nationwide Distribution
Initiated2012-08-22
Classified2013-03-29
Terminated2014-07-21
Recall numberZ-1025-2013
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class III recall — Viscot Medical LLC (Z-1025-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64075/

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