Class III — Viscot Medical LLC
| Recalling firm | VISCOT MEDICAL LLC |
|---|---|
| Registered facility | VISCOT MEDICAL LLC (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Dual Tip Marker has inconsistent ink flow on the black permanent ink side. |
| 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. |
| Quantity | 458,589 markers |
| Distribution | USA Nationwide Distribution |
| Initiated | 2012-08-22 |
| Classified | 2013-03-29 |
| Terminated | 2014-07-21 |
| Recall number | Z-1025-2013 |
| Initiation | Voluntary: 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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