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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69146

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 18, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Smith & Nephew, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

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).

Z-0039-2015
Recall number
Z-0039-2015
Initiated
July 18, 2014
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
19,499 = (10,849 (Item 66800058) & 8,650 (Item 66800913))

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Item 66800058 Lot # M400021 & Item 66800913 Lot # M400067

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.

device · product 2 of 3

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).

Z-0040-2015
Recall number
Z-0040-2015
Initiated
July 18, 2014
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
77,164 = (75,619 (Item 66800423) & 1,545 (Item 66801066))

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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.

device · product 3 of 3

RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) 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).

Z-0041-2015
Recall number
Z-0041-2015
Initiated
July 18, 2014
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
45,466

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Item 66800912 Lot # M400071

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.