Z-0098-2019 Class II Terminated
FDA device recall Z-0098-2019 was initiated by CooperSurgical, Inc. on Sep 4, 2018 and is designated Class II. Reason for recall: The seal of the sterile pouch may be compromised, thereby increasing the risk of infection. The recall status is terminated (terminated May 27, 2020). Affected quantity: 32538.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 17, 2018
- Initiation Date
- Sep 4, 2018
- Termination Date
- May 27, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32538
Product Description
Reason for Recall
Distribution Pattern
The products were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The products were distributed to the following foreign countries: Canada, Columbia, Czech Republic, Germany, Hong Kong, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Russian Federation, Singapore, Slovenia, South Korea, Spain, Switzerland, UAE, and UK.
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-0098-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026