Viscot Medical Recalls Dual Tip Markers Due to Inconsistent Ink Flow
Viscot Medical LLC is recalling 458,589 sterile dual tip markers because the black permanent ink side has inconsistent ink flow.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a functional defect (inconsistent ink flow) rather than a safety hazard like contamination or injury risk.
Plain-English summary
Viscot Medical LLC is recalling 458,589 units of the Dual Tip Marker, Sterile. This product is a writing instrument intended to mark paper and plastic items around the sterile field during surgery. It features two tips: one black for miscellaneous use and one for surgical skin marking.
The recall is being issued because the black permanent ink side of the marker has inconsistent ink flow. The affected products were distributed nationwide in the United States.
The recall includes specific lot numbers: 022043, 022045, 022046, 042084, 042085, 042086, 042087, 042088, 042089, 052128, 052129, 052130, 052131, 062167, 062168, 062169, 062170, 072200, 072201, 072203, 072205, 072206, and 072207, including any letter suffixes after the lot number. Users should check their inventory for these lot numbers and stop using the affected markers.
The recalled product
- 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.
- Manufacturer
- Viscot Medical LLC
- Hazard
- Affected units
- 458,589
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot# 022043
- 022045
- 022046
- 042084
- 042085
- 042086
- 042087
- 042088
- 042089
- 052128
- 052129
- 052130
- 052131
- 062167
- 062168
- 062169
- 062170
- 072200
- 072201
- 072203
Distribution
Distributed nationwide across the United States.
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