CLASS II Device recall · Reported 5 Mar 2014 · FDA Enforcement Report
Renasys EZ, a Canister Component of of Renasys EZ Negative recalled
Smith & Nephew is recalling Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System, distributed nationwide in the US. The recall was initiated on 14 Nov 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1067-2014
- FDA event ID
- 66893
- Recalling firm
- Smith & Nephew, Saint Petersburg, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Nov 2013
- FDA classified
- 21 Feb 2014
- Reported
- 5 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 14 Nov 2013 | Recall initiated by company | |
| 21 Feb 2014 | Classified by FDA | +99 days |
| 5 Mar 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Modification of the bacterial overflow guard (filter) and related changes to product labeling.
Product as listed by the FDA
Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIllinoisIndianaKentuckyLouisianaMassachusettsMichiganMinnesotaMissouriMississippiMontanaNorth Carolina
Questions about this recall
Is Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System recalled?
Yes. Smith & Nephew recalled Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System on 14 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-1067-2014.
Why was it recalled?
Modification of the bacterial overflow guard (filter) and related changes to product labeling.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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