RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients… — Class II medical device recall Z-1597-2024
Ongoing recall by Smith & Nephew Medical, Ltd., reported 2024-04-24, distributed nationwide. Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentia
| Recall number | Z-1597-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew Medical, Ltd., Hull, United Kingdom |
| Recall initiated | 2024-03-11 |
| Classified | 2024-04-18 |
| Reported by FDA | 2024-04-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CL |
| Quantity | 675 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 05000223501082 |
| Lot numbers | 1016051, 1017549 |
Product
RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140
Reason for recall
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
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-1597-2024. 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.