FDA (Devices) recall action 95246
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Low concentration of sodium pyruvate in the wash could compromise gamete development
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
CooperSurgical is recalling Origio Sperm Wash Medium due to low sodium pyruvate concentration. The deficiency could compromise gamete development in assisted reproductive procedures.
CooperSurgical is recalling Origio Sperm Wash Medium due to low sodium pyruvate concentration that could compromise sperm cell development. This affects 980 units distributed worldwide, including throughout the US.
CooperSurgical is recalling Origio Sperm Wash Medium because low sodium pyruvate levels could compromise gamete development.