RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch — Class II medical device recall Z-0615-2021
Terminated recall by Medline Industries Inc, reported 2020-12-23, distributed nationwide. RevMedX Trauma Dressing is being recalled due to package seal integrity.
| Recall number | Z-0615-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries Inc, Northfield, IL, United States |
| Recall initiated | 2020-11-05 |
| Classified | 2020-12-17 |
| Reported by FDA | 2020-12-23 |
| Terminated | 2021-08-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | DK, FR, IL, KE, PL, PT, SG |
| Quantity | 15,780 |
| Reason classes | packaging |
| Lot numbers | 38217070001, 38217080001, 38217080002, 38218050002 |
| Model numbers | NONEX15182W |
Product
RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30 Pouches per Case; Sterile - Product Usage: are intended to absorb exudates.
Reason for recall
RevMedX Trauma Dressing is being recalled due to package seal integrity.
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-0615-2021. 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.