CooperSurgical, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0100-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

MediCult Vitrification Cooling Media, Model Number 12284001F

Product Classification:

Class II

Date Initiated: September 8, 2020

Date Posted: October 21, 2020

Recall Number: Z-0100-2021

Event ID: 86479

Reason for Recall:

There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration Medium (P/N: 12220001) rather than the Vitrification Medium (P/N: 12230001) as indicated on the remainder of the label.

Status: Terminated

Product Quantity: 531 total boxes

Code Information:

Lot: 20230080

Distribution Pattern:

The products were distributed to China.

Voluntary or Mandated:

Voluntary: Firm initiated