FDA Device recall Z-2688-2014
RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as t…
- FDA Device
- Class II
- terminated
- Published 2014-10-01
On 2014-10-01 the FDA classified a Class II recall of RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as t… by Smith And Nephew, citing modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2688-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-13 |
| Published | 2014-10-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Smith And Nephew |
| Distribution | US |
Product
RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.
Reason
Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
Identifiers
| code_info | Model #'s 66800059, all lots since product launched 01/16/2009 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2688-2014%22
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