RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who… — Class II medical device recall Z-0516-2025
Ongoing recall by Smith & Nephew Medical, Ltd., reported 2024-12-04, distributed in AL, CA, CO, FL, HI, IN, KY, NE…. Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintain
| Recall number | Z-0516-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew Medical, Ltd., Hull, United Kingdom |
| Recall initiated | 2024-10-02 |
| Classified | 2024-11-22 |
| Reported by FDA | 2024-12-04 |
| Distributed | AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN, WI |
| Countries outside the US | CA |
| Quantity | 1,589 units |
| UPC / GTIN / UDI-DI | 05000223498634 |
| Serial numbers | PEAB230001, PEAB230002, PEAB230003, PEAB230006, PEAB230011, PEAB230014, PEAB230021, PEAB230022, PEAB230027, PEAB230028, PEAB230032, PEAB230033, PEAB230036, PEAB230037, PEAB230039, PEAB230041, PEAB230042, PEAB230044, PEAB230048, PEAB230050, PEAB230051, PEAB230052, PEAB230053, PEAB230054, PEAB230057 and 475 more |
| Model numbers | 66803126, 66803126LRC |
Product
RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.
Reason for recall
Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
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-0516-2025. 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.