Z-1044-2023Class II

BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for...

Name: Z-1044-2023 BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for...
Creator: CooperSurgical, Inc.
Published: 2022-12-15
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2022-12-15 / Open, Classified / root cause: labeling and UDI

FDA source

CooperSurgical, Inc. began a recall of BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD) on 2022-12-15. FDA classified it as Class II and gives the reason as "The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1044-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-15
Posted: 2023-01-31
Recalling firm: CooperSurgical, Inc.
Product: BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)
Product code: MQL Media, Reproductive
Reason for recall: The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: An "URGENT: VOLUNTARY MEDIA RECALL" letter dated 12/13/22 was sent to customers. Actions to be Taken: For both CUSTOMERS and DISTRIBUTORS: Inspect your stock for the Product from this lot. Lot information can be found on the box and bottle labeling. o If found, quarantine, and discontinue use of the Product from this lot immediately. o Return the Product to CooperSurgical through our Recall Return process. Credit will be applied to your account for reorder of correct product per our Recall process with no additional cost to you or your facilities. For CUSTOMERS: If you have the affected Product, contact CooperSurgical at [email protected]. Or call +1-203-601-5200 and follow the phone prompt to enter the ext. 3300. If you received this letter (even if you do not have the specific lot remaining in stock), please complete and return the enclosed Customer Acknowledgement Form to [email protected]. For DISTRIBUTORS: If the Product has been distributed to your customers, send this letter (including the Customer Acknowledgement Form) to your customers. Complete and return the enclosed Distributor Acknowledgement and Receipt Form to [email protected]. Please feel free to reach us at +1-203-601-5200 and follow the phone prompt to enter the ext. 3300 or via email at [email protected].
Quantity in commerce: 489 units
Distribution: Global Distribution including countries of: Bahrain, Belgium, Bulgaria, Egypt, France, Georgia, Greece, Hong Kong, Iran, Iraq, Israel, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Nigeria, Oman, Pakistan, Poland, Republic of North Macedonia, Saudi Arabia, Slovenia, Spain, Thailand, Turkey, Turkmenistan, and United Arab Emirates.
Product codes and lots: Lot Number: 220506-006557

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1044-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1044-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-31

Product code MQL

K060983Class IIBiopsy Medium, Model Ref 1062Medicult A/S / cleared 2006-07-28

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)