Uromedica Inc.: Medical Device Recall in 2022 - (Recall #: Z-0458-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.

Product Classification:

Class II

Date Initiated: November 22, 2021

Date Posted: January 12, 2022

Recall Number: Z-0458-2022

Event ID: 89184

Reason for Recall:

The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.

Status: Terminated

Product Quantity: 18 devices

Code Information:

Lot numbers UM00794 and UM00817, UDI 00180668000106

Distribution Pattern:

US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI.

Voluntary or Mandated:

Voluntary: Firm initiated