Sage In-Vitro Fertilization- CSC — Class III medical device recall Z-2851-2016
Terminated recall by CooperSurgical, Inc., reported 2016-09-28, distributed nationwide. Products contain international package insert and not the correct USA package insert
| Recall number | Z-2851-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2016-08-25 |
| Classified | 2016-09-20 |
| Reported by FDA | 2016-09-28 |
| Terminated | 2017-02-01 |
| Distributed | Nationwide (US) |
| Quantity | 4 units |
| Lot numbers | 15430149, 16140184 |
| Expiration dates | 2016-10-20, 2017-04-20 |
Product
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezing embryos. This product is intended for thawing of embryos frozen with ART-8017, CSC Freezing Medium. This kit is designed to be used in conjunction with the SAGE CSC Freezing Medium Kit (ART-8017).
Reason for recall
Products contain international package insert and not the correct USA package insert
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-2851-2016. 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.