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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 980
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.
Part of a larger recall action
This product is one of 3 recalled by CooperSurgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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