Brand Name: IMed Products Product Name: Dressing Change Kit with… — Class II medical device recall Z-1012-2025
Ongoing recall by Trinity Sterile, Inc., reported 2025-01-29, distributed nationwide. Potential for hole in package compromising sterility of the medical kit.
| Recall number | Z-1012-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Trinity Sterile, Inc., Salisbury, MD, United States |
| Recall initiated | 2024-12-13 |
| Classified | 2025-01-22 |
| Reported by FDA | 2025-01-29 |
| Distributed | Nationwide (US) |
| Quantity | 1,980 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10853155008769 |
| Lot numbers | 600022 |
| Model numbers | IM46062 |
Product
Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 66 cases affected. Component: No
Reason for recall
Potential for hole in package compromising sterility of the medical kit.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1012-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.