Z-3296-2024Class II

Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A

Name: Z-3296-2024 Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A
Creator: CooperSurgical, Inc.
Published: 2024-02-16
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2024-02-16 / Open, Classified

FDA source

CooperSurgical, Inc. began a recall of Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A on 2024-02-16. FDA classified it as Class II and gives the reason as "Low concentration of sodium pyruvate in the wash could compromise gamete development". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-3296-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-16
Posted: 2024-09-26
Recalling firm: CooperSurgical, Inc.
Product: Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A
Product code: MQL Media, Reproductive
Reason for recall: Low concentration of sodium pyruvate in the wash could compromise gamete development
FDA root cause: Under Investigation by firm
Action: CooperSurgical issued Urgent: Voluntary Medical Device Field Safety Notice on 2/16/24 via UPS Next Day Air via third party Sedgewick. Letter states reason for recall, health risk and action to take: 1) Inspect your inventory, quarantine any affected product, and immediately stop using the product. 2) Complete the appropriate version of the attached form (Customer Acknowledgement Form or Distributor Acknowledgement Form). Once completed, return the form to CooperSurgical as indicated at the top of the form. Note: Even if you do not have any affected product in your inventory ( or have not distributed any affected product to customers), please complete and return the enclosed form so that we may document receipt of this FSN. When the completed form is received by CooperSurgical, arrangements will be made for the return of any affected product at no additional cost to you. Credit will be applied to your account for product returned under this action. CooperSurgical is committed to high-quality, safe, and effective products. This corrective action has been initiated to ensure this failure mode does not reoccur and future potential patient harms can be avoided. If you have any questions, please feel free to reach us at +1 203-601-5200 ext. 3300 or [email protected].
Quantity in commerce: 980 units
Distribution: Worldwide distribution - US Nationwide.
Product codes and lots: UDI: 20888937816536 Lot 230922-018006 Expiration date: 20 September 2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3296-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3296-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3297-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3298-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26

Product code MQL

K153267Class IIORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm WashOrigio A/S / cleared 2016-07-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)