CooperSurgical Recalls Origio Sperm Wash Medium Due to Low Sodium Pyruvate
CooperSurgical is recalling Origio Sperm Wash Medium because low sodium pyruvate levels could compromise gamete development.
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: The recall is classified as FDA Class II. The hazard involves a risk of harm to gamete development, but the source text does not report any illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
CooperSurgical, Inc. is recalling 2,680 units of Origio Sperm Wash Medium, Pack of Five 60ml bottles (Part Number: 84055060A). The affected product is identified by UDI 20888937816543, Lot 230922-018008, and an expiration date of September 20, 2024.
The recall was initiated because a low concentration of sodium pyruvate in the wash could compromise gamete development. This product is intended for the washing of spermatozoa.
The affected units were distributed worldwide and nationwide in the United States. Consumers and healthcare providers should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 2,680
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: 20888937816543 Lot 230922-018008 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.
See all 3 products in this recall →Related recalls
Same manufacturer · CooperSurgical, Inc.
See all →- SevereCooperSurgical Recalls Neonatal Nasal CPAP Replacement Sets Due to Loose Tubing
FDA (Devices) · 2026-09-30
- SevereCooperSurgical Recalls Infant Nasal CPAP Tubing Due to Loose Connection Risk
FDA (Devices) · 2026-09-30
- HighEndosee system convenience trays label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
- HighHSG procedure trays label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
- HighEndosee convenience kits label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
Same hazard · chemical concentration
See all →- SevereFresenius Recalls NaturaLyte Liquid Acid Concentrate Bottles
FDA (Devices) · 2021-01-20
- HighFresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels
FDA (Devices) · 2021-01-20
- HighFresenius Citrasate Liquid Acid Concentrate Recalled for Low Sodium and Calcium Levels
FDA (Devices) · 2021-01-20
- HighFresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels
FDA (Devices) · 2021-01-20
- HighFresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels
FDA (Devices) · 2021-01-20
Similar recalls
- LowCooperSurgical Recalls Wallace Catheters Due to Expiration Date Error
FDA (Devices) · 2020-04-22
- HighBiopsy Medium for In Vitro Fertilization Recalled Due to Product Contamination
FDA (Devices) · 2023-02-08
- LowCooperSurgical Recalls Sage CSC Thawing Medium Due to Incorrect Package Insert
FDA (Devices) · 2016-09-28
- HighLife Technologies Recalls Gibco Sodium Pyruvate Due to Leaky Bottle Caps
FDA (Devices) · 2018-10-24
- SevereHydroxyprogesterone Caproate Injectable Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2014-11-12
- ModerateSperm separation media kits recalled for incorrect component lot
FDA (Devices) · 2024-02-14