Zien Medical PenBlade Safety Scalpel Recalled for Sterile Barrier Risk
Zien Medical Technologies is recalling PenBlade Safety Scalpels because cracks in the PET trays may compromise the sterile barrier.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zien Medical Technologies, Inc. is recalling specific models of PenBlade Safety Scalpels (PB-M-10, PB-M-11P, and PB-M-15) due to a defect in the packaging. Cracks were discovered in the PET trays of a small population of sterile product, which creates a risk of loss of the sterile barrier for the product.
Sampling and root cause analysis indicated that the risk could extend throughout the lots manufactured from September 2014 to July 2015. The affected units were distributed worldwide to the U.S. nationwide, Germany, and England. The total quantity of product involved in the recall is 28,284 units.
Healthcare providers and consumers should stop using the affected scalpels and contact Zien Medical Technologies for instructions on returning the product. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 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
- Manufacturer
- Zien Medical Technologies, Inc
- Hazard
- Affected units
- 28,284
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 (18)
- Product Code PB-M-10
- Lots 140901J-A
- 150228PB10
- 150509PB10
- 150510PB10
- Product Code PB-M-11P
- Lots 140901J-B
- 150227PB11
- 150318PB11
- 150509PB11
- 150510PB11
- Product Code PB-M-15
- Lots 140901J-C
- 150226PB15
- 150326PB15
- 150511PB15
- 150512PB15
- 150529PB15.
Distribution
Distributed nationwide across the United States.
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