1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24215; 3. Sydney IVF¿ Embryo Transfer Set, Product Number: K-JETS-7019-SIVF, Global Product Number: G18740

Reason: Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and/or nonviable embryos.

Code information: 1. Catalog Number: K-J-SMS-571800, Lot Number: 6802704, Expiration Date: 3/10/2019; 2. Catalog Number: K-JETS-551910-L, Lot Number: NS6360603, Expiration Date: 11/15/2018; 3. Catalog Number: K-JETS-7019-SIVF, Lot Number: 6503675, Expiration Date: 2/2/2019

Distribution pattern: Worldwide Distribution - U.S. Nationwide in the states of: CA, CO, FL, IN, MA, NE, NJ, OH, TN, TX, and WI. and countries of Belarus, Belgium, Brazil, Canada, Chile, China, Egypt, Italy, Japan, Poland, Saudi Arabia, Spain, and United Kingdom.