Origio Sperm Wash Medium Recalled Due to Low Sodium Pyruvate
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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall affecting a reproductive medicine product. While the defect—low sodium pyruvate concentration—could compromise gamete development, no adverse events or injuries have been reported. The classification reflects the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
CooperSurgical, Inc. is recalling Origio Sperm Wash Medium, a medical device used in assisted reproductive procedures to wash spermatozoa. The recalled batches contain insufficient concentration of sodium pyruvate, which could compromise sperm cell development during processing.
The recall affects 980 units of the ten-pack bottles (part number 84051010A) with lot number 230922-018006 and expiration date September 20, 2024. These units were distributed worldwide, including throughout the United States.
The FDA has classified this as a Class II recall. No adverse events or injuries related to this defect have been reported to date.
The recalled product
- Product
- Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- sodium-pyruvate-deficiency
- gamete-development-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 20888937816536 Lot 230922-018006 Expiration date: 20 September 2024
Distribution
Distributed nationwide across the United States.
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