FDA Device recall Z-0040-2015
RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collec…
- FDA Device
- Class II
- terminated
- Published 2014-10-15
On 2014-10-15 the FDA classified a Class II recall of RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collec… by Smith And Nephew, citing RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0040-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-18 |
| Published | 2014-10-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Smith And Nephew |
| Distribution | US |
Product
RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Reason
RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
Identifiers
| code_info | Item 66800423 Lot # M400058 & Item 66801066 Lot # M400124 |
|---|
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-0040-2015%22
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