Z-1089-2024 Class II Ongoing
FDA device recall Z-1089-2024 was initiated by CooperSurgical, Inc. on December 20, 2023 and is designated Class II. Reason for recall: The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage. The recall status is ongoing. Affected quantity: 994 total (481 US; 513 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2024
- Initiation Date
- December 20, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 994 total (481 US; 513 OUS)
Product Description
Reason for Recall
Distribution Pattern
Worldwide - US Nationwide including in the states of AL, AZ, CA, CO, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MO, NV, NJ, NM, NY, NC, OH, OK, OR, PA, RI, TN, TX, UT, VT, VA, WA, WV and the countries of Canada, Brazil, Mexico, Argentina, Hong Kong, Japan, Turkey, Netherlands, Belgium, Spain, Taiwan, United Kingdom, Austria, Georgia, France, Denmark, Greece, Saudi Arabia, Thailand, New Zealand, Estonia, Poland, Jordan, and Germany.