Data Foundry

Medical device recalls 2013

Non-sterile Viscot Surgical Skin Markers Part Number 1437-100… — Class II medical device recall Z-1872-2013

Terminated recall by Precision Dynamics Corporation, reported 2013-08-14, distributed in OK, SC, TN, TX, WA. PDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Markers, becuase

Recall numberZ-1872-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPrecision Dynamics Corporation, Valencia, CA, United States
Recall initiated2013-07-10
Classified2013-08-02
Reported by FDA2013-08-14
Terminated2014-01-06
DistributedOK, SC, TN, TX, WA
Quantity1,200 pens
Reason classeslabeling, sterility
Lot numbers061313
Model numbers143-100, 1437-100

Product

Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement; available in nonsterile configuration.

Reason for recall

PDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Markers, becuase they were inadvertently mislabeled as PN STER-VIS Sterile Skin Marker Pen with Labels and Flex Ruter.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1872-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.