Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BIOPSY MEDIUM 10ML Recalled by CooperSurgical, Inc. Due to The affected product may contain a medium other...

Date: December 15, 2022
Company: CooperSurgical, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact CooperSurgical, Inc. directly.

Affected Products

BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)

Quantity: 489 units

Why Was This Recalled?

The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo.

Where Was This Sold?

Global Distribution including countries of: Bahrain, Belgium, Bulgaria, Egypt, France, Georgia, Greece, Hong Kong, Iran, Iraq, Israel, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Nigeria, Oman, Pakistan, Poland, Republic of North Macedonia, Saudi Arabia, Slovenia, Spain, Thailand, Turkey, Turkmenistan, and United Arab Emirates.

About CooperSurgical, Inc.

CooperSurgical, Inc. has 83 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report