Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium… — Class II medical device recall Z-0617-2025
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-0617-2025 |
|---|---|
| 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 | 3,900 boxes |
| Reason classes | sterility |
| Lot numbers | W00070134 |
| Model numbers | 529937R |
Product
Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic and acute wounds such as: ¿ pressure ulcers ¿ leg ulcers ¿ cavity wounds ¿ lacerations ¿ post-operative surgical 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-0617-2025. 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.