Smith & Nephew, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0040-2015)

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/ 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).

Product Classification:

Class II

Date Initiated: July 18, 2014

Date Posted: October 15, 2014

Recall Number: Z-0040-2015

Event ID: 69146

Reason for Recall:

RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

Status: Terminated

Product Quantity: 77,164 = (75,619 (Item 66800423) & 1,545 (Item 66801066))

Code Information:

Item 66800423 Lot # M400058 & Item 66801066 Lot # M400124

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of FL, NC, CA, MO, MA, TX, NY, OH, CO, VA, IL, NJ, TN, NV, MN including Puerto Rico and countries of Canada, Mexico, Dubai, Argentina, Australia, Colombia, Germany, Hong Kong, Jordon, Malaysia, Thailand, Tunisia, New Zealand, South Africa, Shanghai, Brazil, Saudi Arabia and Lebanon.

Voluntary or Mandated:

Voluntary: Firm initiated