Uromedica Inc.: Medical Device Recall in 2020 - (Recall #: Z-1808-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced.

Product Classification:

Class II

Date Initiated: April 10, 2019

Date Posted: May 6, 2020

Recall Number: Z-1808-2020

Event ID: 85486

Reason for Recall:

Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when passes through the sheaths.

Status: Terminated

Product Quantity: 11 tool sets

Code Information:

Model 750041, Lot # UM00650

Distribution Pattern:

Nationwide distribution to the following states: CA, GA, FL, MI, and VA.

Voluntary or Mandated:

Voluntary: Firm initiated