FDA Device recall Z-1016-2025
Brand Name: Tacy Medical, Inc
- FDA Device
- Class II
- ongoing
- Published 2025-01-29
On 2025-01-29 the FDA classified a Class II recall of Brand Name: Tacy Medical, Inc by Trinity Sterile, citing potential for hole in package compromising sterility of the medical kit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1016-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-13 |
| Published | 2025-01-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Trinity Sterile |
| Distribution | US |
Product
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
Reason
Potential for hole in package compromising sterility of the medical kit.
Identifiers
| code_info | Model No TM6180CP, UDI-DI 58500425700020, Lot Number 600032 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1016-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.