FDA Device recall Z-1596-2024
RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound h…
- FDA Device
- Class II
- ongoing
- Published 2024-04-24
On 2024-04-24 the FDA classified a Class II recall of RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound h… by Smith And Nephew Medical, citing black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1596-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-11 |
| Published | 2024-04-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Smith And Nephew Medical |
| Distribution | US |
Product
RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139
Reason
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
Identifiers
| code_info | GTIN: (01)05000223501044 Lot Numbers: 1016448, 1016478, 1016537, 1016773, 1017147, 1017417, 1017418, 1017912, 1016044 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1596-2024%22
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