Smith & Nephew, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2688-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: August 13, 2014

Date Posted: October 1, 2014

Recall Number: Z-2688-2014

Event ID: 69137

Reason for Recall:

Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.

Status: Terminated

Product Quantity: 2,142 units

Code Information:

Model #'s 66800059, all lots since product launched 01/16/2009

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated