Valeritas, Incorporated: Medical Device Recall in 2019 - (Recall #: Z-0197-2020)

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:

DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01

Product Classification:

Class II

Date Initiated: July 3, 2019

Date Posted: November 6, 2019

Recall Number: Z-0197-2020

Event ID: 83386

Reason for Recall:

There is a potential for "No Needle Demo Units" to contain a needle.

Status: Terminated

Product Quantity: 21,714 devices

Code Information:

UDI: (01)10385609020015(17)XXXXXX(10)XXXXXXXX Lot Numbers: DM418011 DM418012 DM418013 DM418014 DM418015 DM418016 DM418017 DM418031 DM418033 DM418037

Distribution Pattern:

Nationwide within U.S.

Voluntary or Mandated:

Voluntary: Firm initiated