FDA Device recall Z-0516-2025
RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing…
- FDA Device
- Class II
- ongoing
- Published 2024-12-04
On 2024-12-04 the FDA classified a Class II recall of RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing… by Smith And Nephew Medical, citing due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0516-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-02 |
| Published | 2024-12-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Smith And Nephew Medical |
| Distribution | AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN, WI |
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
Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
Identifiers
| code_info | Model Numbers: 66803126, 66803126LRC UDI-DI codes: 05000223498634 Serial Numbers: PEAB230001 PEAE230422 PEAF230180 PEAG…Model Numbers: 66803126, 66803126LRC UDI-DI codes: 05000223498634 Serial Numbers: PEAB230001 PEAE230422 PEAF230180 PEAG230269 PEAH230208 PEAH230859 PEAJ230484 PEAB230002 PEAE230423 PEAF230181 PEAG230271 PEAH230209 PEAH230861 PEAJ230490 PEAB230003 PEAE230427 PEAF230185 PEAG230272 PEAH230210 PEAH230862 PEAJ230491 PEAB230006 PEAE230428 PEAF230186 PEAG230273 PEAH230211 PEAH230863 PEAJ230492 PEAB230011 PEAE230429 PEAF230188 PEAG230275 PEAH230212 PEAH230865 PEAJ230493 PEAB230014 PEAE230432 PEAF230189 PEAG230277 PEAH230214 PEAH230867 PEAJ230497 PEAB230021 PEAE230433 PEAF230190 PEAG230279 PEAH230215 PEAH230868 PEAJ230499 PEAB230022 PEAE230434 PEAF230199 PEAG230280 PEAH230216 PEAH230871 PEAJ230502 PEAB230027 PEAE230436 PEAF230202 PEAG230282 PEAH230217 PEAH230872 PEAJ230505 PEAB230028 PEAE230437 PEAF230203 PEAG230283 PEAH230218 PEAH230874 PEAJ230512 PEAB230032 PEAE230438 PEAF230208 PEAG230285 PEAH230219 PEAH230875 PEAJ230513 PEAB230033 PEAE230439 PEAF230209 PEAG230287 PEAH230220 PEAH230876 PEAJ2 |
|---|
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-0516-2025%22
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