Z-1067-2014 Class II Terminated
FDA device recall Z-1067-2014 was initiated by Smith & Nephew Inc. on Nov 14, 2013 and is designated Class II. Reason for recall: Modification of the bacterial overflow guard (filter) and related changes to product labeling. The recall status is terminated (terminated Aug 4, 2014). Affected quantity: 6,799,140 canisters EZ & EZ PLUS.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 5, 2014
- Initiation Date
- Nov 14, 2013
- Termination Date
- Aug 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,799,140 canisters EZ & EZ PLUS
Product Description
Reason for Recall
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.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1067-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026