Z-0039-2015Class II

RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier

Name: Z-0039-2015 RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier
Creator: Smith & Nephew, Inc.
Published: 2014-07-18
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2014-07-18 / Terminated / root cause: design

FDA source

Smith & Nephew, Inc. began a recall of RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate... on 2014-07-18. FDA classified it as Class II and gives the reason as "RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0039-2015
Classification: Class II
Status: Terminated
Initiated: 2014-07-18
Posted: 2014-10-08
Terminated: 2015-08-05
Recalling firm: Smith & Nephew, Inc.
Product: RENASYS EZ/ RENASYS EZ Plus 250 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 code: OMP Negative Pressure Wound Therapy Powered Suction Pump
Reason for recall: RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
Root cause tag: design
FDA root cause: Device Design
Action: Smith & Nephew sent an Urgent Medical Device Correction Notice dated July 15, 2014 to all US customers via Federal Express delivery. The letter identified the affected product, problem and actions to be taken. The firm instructed customers to discard the affected product and replace with a new one from an unaffected lot. For questions contact 727-399-3785.
Quantity in commerce: 19,499 = (10,849 (Item 66800058) & 8,650 (Item 66800913))
Distribution: 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.
Product codes and lots: Item 66800058 Lot # M400021 & Item 66800913 Lot # M400067

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0039-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0039-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-08
Z-0040-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-08
Z-0041-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-08

Product code OMP

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)