Origio Sperm Wash Medium Recalled for Low Sodium Pyruvate Concentration
CooperSurgical is recalling Origio Sperm Wash Medium due to low sodium pyruvate concentration. The deficiency could compromise gamete development in assisted reproductive procedures.
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 an FDA Class II medical device recall with a theoretical risk-of-harm condition (low sodium pyruvate could compromise gamete development) and no reported illnesses or injuries. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a High (3) rating.
Plain-English summary
CooperSurgical, Inc. is recalling Origio Sperm Wash Medium, a medical device pack of five 60ml bottles (Part Number 84055060D) used to wash spermatozoa.
The recall was initiated due to a low concentration of sodium pyruvate in the wash. This low concentration could compromise gamete development.
This recall affects 770 units distributed worldwide, including throughout the United States. The affected lot is 230922-018009, with an expiration date of September 20, 2024. Users of the recalled product should contact CooperSurgical for appropriate follow-up instructions.
The recalled product
- Product
- Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 770
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: 20888937816918 Lot 230922-018009 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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