Z-3278-2018 Class II Terminated
FDA device recall Z-3278-2018 was initiated by CooperSurgical, Inc. on Sep 4, 2018 and is designated Class II. Reason for recall: There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection. The recall status is terminated (terminated Apr 15, 2020). Affected quantity: 18,000 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 3, 2018
- Initiation Date
- Sep 4, 2018
- Termination Date
- Apr 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,000 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution n- US Nationwide in the states of: AL, AR, AZ, CA, CT, DC, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SC, TX, VA, WA and WV, and the following foreign countries of: Australia, Canada, Colombia, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, Russian Federation, Saudi Arabia, Singapore, Spain, Switzerland, Turkey, and the United Kingdom.
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-3278-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026