CellEra LLC: Medical Device Recall in 2019 - (Recall #: Z-2085-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144

Product Classification:

Class II

Date Initiated: September 1, 2016

Date Posted: July 31, 2019

Recall Number: Z-2085-2019

Event ID: 83281

Reason for Recall:

Adhesive border was not sticky enough.

Status: Terminated

Product Quantity: 2110 units

Code Information:

Lot # 161616 Cat. No. 20144 HIBCC bar code was M6692014409

Distribution Pattern:

OH, PA, VA

Voluntary or Mandated:

Voluntary: Firm initiated