FDA Device recall Z-0617-2025
Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic…
- FDA Device
- Class II
- ongoing
- Published 2024-12-11
On 2024-12-11 the FDA classified a Class II recall of Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic… by Advanced Medical Solutions, citing due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0617-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-01 |
| Published | 2024-12-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Advanced Medical Solutions |
| Distribution | US |
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
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Identifiers
| code_info | Model Number: 529937R UDI-DI code: 0060075029530 Lot Number: W00070134 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Advanced Medical Solutions
- McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to cont…
FDA Device · Class II · 2024-12-11 · Advanced Medical Solutions - MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048…
FDA Device · Class II · 2024-12-11 · Advanced Medical Solutions - ReliaMed¿ Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) hold…
FDA Device · Class II · 2016-09-14 · Advanced Medical Solutions - ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packagin…
FDA Device · Class II · 2016-09-14 · Advanced Medical Solutions
All Advanced Medical Solutions recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0617-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.