Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66893

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

Open FDA event record

Event summary

Timeline bucket
November 14, 2013
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

2 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 2

Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System

Z-1067-2014
Recall number
Z-1067-2014
Initiated
November 14, 2013
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew Inc.
Quantity
6,799,140 canisters EZ & EZ PLUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Modification of the bacterial overflow guard (filter) and related changes to product labeling.

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

Modification of the bacterial overflow guard (filter) and related changes to product labeling.

Code information

Product code: 66800912 - 800ml canister with solidifier 66800913 - 250ml canister with solidifier 66801066 - 800ml canister without solidifier 66800423 - 800ml canister with solidifier 66800058 - 250ml canister with solidifier Lot codes - M201498 thru M400299

Distribution pattern

Worldwide Distribution: USA (nationwide) including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NH, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, WV, and Puerto Rico; and the countries of: Austria, Australia, Belgium, Switzerland, China, Cyprus, Germany, Denmark, Spain, Finland, France, UK, Greece, Israel, Italy, Malta, Netherlands, Norway, Paraguay, Russia, Saudi Arabia, Sweden, Thailand, Turkey, South Africa, Mexico, and Canada.

device · product 2 of 2

Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System

Z-1068-2014
Recall number
Z-1068-2014
Initiated
November 14, 2013
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew Inc.
Quantity
6,871,375 canisters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Modification of the bacterial overflow guard (filter) and related changes to product labeling.

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

Modification of the bacterial overflow guard (filter) and related changes to product labeling.

Code information

Product code: 66800912 - 800ml canister with solidifier 66800913 - 250ml canister with solidifier 66801066 - 800ml canister without solidifier 66800423 - 800ml canister with solidifier 66800058 - 250ml canister with solidifier Lot codes - M201498 thru M400299

Distribution pattern

Worldwide Distribution: USA (nationwide) including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NH, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, WV, and Puerto Rico; and the countries of: Austria, Australia, Belgium, Switzerland, China, Cyprus, Germany, Denmark, Spain, Finland, France, UK, Greece, Israel, Italy, Malta, Netherlands, Norway, Paraguay, Russia, Saudi Arabia, Sweden, Thailand, Turkey, South Africa, Mexico, and Canada.