CooperSurgical, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2850-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: August 25, 2016

Date Posted: September 28, 2016

Recall Number: Z-2850-2016

Event ID: 75094

Reason for Recall:

Products contain international package insert and not the correct USA package insert

Status: Terminated

Product Quantity: 1 unit

Code Information:

Lot No. 15420123 Expires Oct. 2016

Distribution Pattern:

Nationwide Distribution to CA, GA, and NY

Voluntary or Mandated:

Voluntary: Firm initiated