Zien Medical Technologies, Inc: Medical Device Recall in 2015 - (Recall #: Z-2800-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 18, 2015

Date Posted: September 30, 2015

Recall Number: Z-2800-2015

Event ID: 72038

Reason for Recall:

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.

Status: Terminated

Product Quantity: 28,284

Code Information:

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 Pattern:

Worldwide distribution to U.S. nationwide, Germany and England.

Voluntary or Mandated:

Voluntary: Firm initiated