Food, drugs, devices › CooperSurgical, Inc.
Device recall: Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE
CooperSurgical, Inc. (Trumbull, CT) initiated this device recall on 25 Aug 2016; FDA lists 2 product records under event 75094, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 5% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 1 Feb 2017. Initiation: voluntary: firm initiated. CooperSurgical, Inc. has 57 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
CooperSurgical, Inc., Trumbull, CT.
Reason for recall
"Products contain international package insert and not the correct USA package insert"
Distribution
"Nationwide Distribution to CA, GA, and NY"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2850-2016 | Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE In Vitro Fertilization, Inc. A CooperSurgical Company 95 Corporate Drive Trumbull, CT 06611 USA | 1 unit | Class III | Terminated | 28 Sep 2016 |
| Z-2851-2016 | 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… | 4 units | Class III | Terminated | 28 Sep 2016 |
Context
Other enforcement events for CooperSurgical, Inc.
All 57 events for CooperSurgical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Products contain international package insert and not the correct USA package insert"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution to CA, GA, and NY"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 1 Feb 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.