MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP… — Class II medical device recall Z-0619-2025
Ongoing recall by Advanced Medical Solutions Ltd., reported 2024-12-11, distributed nationwide. Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
| Recall number | Z-0619-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Medical Solutions Ltd., Winsford, United Kingdom |
| Recall initiated | 2024-10-01 |
| Classified | 2024-12-04 |
| Reported by FDA | 2024-12-11 |
| Distributed | Nationwide (US) |
| Quantity | 1,800 boxes |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10080196296828, 10080196296842 |
| Lot numbers | W00070789, W00070988 |
| Model numbers | MSC7044EP, MSC7048EP |
Product
MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.
Reason for recall
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
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-0619-2025. 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.