Trinity Sterile, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1016-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description: Dressing change tray, case of 20, lot #600032, 50 cases affected. Component: No

Product Classification:

Class II

Date Initiated: December 13, 2024

Date Posted: January 29, 2025

Recall Number: Z-1016-2025

Event ID: 96068

Reason for Recall:

Potential for hole in package compromising sterility of the medical kit.

Status: Ongoing

Product Quantity: 280 units

Code Information:

Model No TM6180CP, UDI-DI 58500425700020, Lot Number 600032

Distribution Pattern:

US Nationwide distribution in the states of MD, PA, TN and TX.

Voluntary or Mandated:

Voluntary: Firm initiated