Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage — Class II medical device recall Z-1828-2024
Ongoing recall by Andover Healthcare Inc., reported 2024-05-22, distributed nationwide. A packaging seal gap could impact the sterility of the product.
| Recall number | Z-1828-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Andover Healthcare Inc., Salisbury, MA, United States |
| Recall initiated | 2024-04-02 |
| Classified | 2024-05-15 |
| Reported by FDA | 2024-05-22 |
| Distributed | Nationwide (US) |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10724004641072 |
| Lot numbers | 0031151359, 10009897233 |
| Model numbers | 5400S |
Product
Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
Reason for recall
A packaging seal gap could impact the sterility of the product.
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-1828-2024. 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.