1 — Class II medical device recall Z-1188-2018
Terminated recall by Cook Inc., reported 2018-04-04, distributed nationwide. Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quali
| Recall number | Z-1188-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2017-12-19 |
| Classified | 2018-03-26 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2019-04-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BR, CA, CL, CN, EG, ES, GB, IT, JP, PL, SA |
| Quantity | 473 |
| Lot numbers | 6503675, 6802704, NS6360603 |
| Model numbers | K-J-SMS-571800, K-JETS-551910-L, K-JETS-7019-SIVF |
| Expiration dates | 2018-11-15, 2019-02-02, 2019-03-10 |
Product
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1188-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.