Z-2688-2014Class II

RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a...

Name: Z-2688-2014 RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a...
Creator: Smith & Nephew, Inc.
Published: 2014-08-13
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2014-08-13 / Terminated

FDA source

Smith & Nephew, Inc. began a recall of RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may... on 2014-08-13. FDA classified it as Class II and gives the reason as "Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2688-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-13
Posted: 2014-09-23
Terminated: 2015-08-06
Recalling firm: Smith & Nephew, Inc.
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.
Product code: OMP Negative Pressure Wound Therapy Powered Suction Pump
Reason for recall: Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
FDA root cause: No Marketing Application
Action: All RENASYS EZ Products will be removed from the field and customers will be transitioned to other product. On August 13, 2014 the firm sent an "Urgent- Medical Device Removal RENASYS EZ" notification via FedEx overnight asking that the use of the RENASYS EZ should be immediately discontinued and the device should be returned to Smith & Nephew. If you have questions, please reach out to your Customer Care representative or call 1-800-876-1261 Monday through Friday, 8:00 AM to 6:00 PM, Eastern Time.
Quantity in commerce: 2,142 units
Distribution: Worldwide Distribution- US (nationwide) including MA, MN, NY and Puerto Rico; Canada, Mexico, Dubai, Australia, Chile, Colombia, Germany, France, England, Spain, Italy, Norway, Hong Kong, Shanghai, New Zealand, South Africa, Singapore, Japan, Thailand and the Caribbean Islands.
Product codes and lots: Model #'s 66800059, all lots since product launched 01/16/2009

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2688-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2688-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-23

Product code OMP

K082426Class IIRenasys EzSmith & Nephew, Inc. / cleared 2008-09-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)