Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PenBlade Safety Scalpel Recalled by Zien Medical Technologies, Inc Due to Cracks were discovered in the PET tray of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zien Medical Technologies, Inc directly.
Affected Products
PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15
Quantity: 28,284
Why Was This Recalled?
Cracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk of loss of sterile barrier for the product. Sampling and root cause analysis indicated that the risk could extend throughout the lots manufactured from September 2014-July 2015. This led to the decision to recall the product.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zien Medical Technologies, Inc
Zien Medical Technologies, Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report