Norm-Ject Tuberkulin Syringe — Class II medical device recall Z-1185-2018
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-1185-2018 |
|---|---|
| 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 | 1,900 |
| Lot numbers | 5667080 |
| Model numbers | K-ATS-1000 |
| Expiration dates | 2019-11-30, 2020-04-30 |
Product
Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
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-1185-2018. 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.