The Recall Desk
HighFDA (Devices)·Z-1016-2025·Announced 2025-01-29

Dressing Change Tray Recalled Due to Potential Package Sterility Compromise

Trinity Sterile's Dressing Change Tray (Model TM6180CP, Lot 600032) is recalled because of a potential hole in the package that could compromise sterility. The recall affects 280 units distributed across Maryland, Pennsylvania, Tennessee, and Texas.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for a medical device with potential sterility compromise due to package breach. No reported illnesses or injuries; the hazard is theoretical, so the score is capped at 3 per the rubric.

Plain-English summary

Trinity Sterile, Inc. is recalling the Dressing Change Tray CS/20 (Model TM6180CP, Lot 600032) due to a potential hole in the package that may compromise the sterility of the medical kit.

The recalled product is a dressing change tray sold in cases of 20 units. A total of 280 units across 50 cases have been affected. These units were distributed to healthcare facilities and providers in Maryland, Pennsylvania, Tennessee, and Texas.

Consumers should not use the affected product and should contact their healthcare provider or the manufacturer for guidance on replacement or proper disposal.

The recalled product

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
Manufacturer
Trinity Sterile, Inc.
Category
Medical Device — Wound Care Supplies
Hazard
Affected units
280

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Trinity Sterile, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · Trinity Sterile, Inc.

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Same hazard · package breach

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