FDA Medical Device Recalls (openFDA)
CooperSurgical, Inc.: BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)
- Recall number
- Z-1044-2023
- 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)
- Status
- Open, Classified
- Initiated
- 2022-12-15
- Posted
- 2023-01-31
- Terminated
- not on file
- Reason
- 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
- 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 Recall@coopersurgical.com. 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 Recall@coopersurgical.com. 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 Recall@coopersurgical.com. 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 Recall@coopersurgical.com.
- Quantity
- 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.
- Lot, serial or model codes
- Lot Number: 220506-006557
- 510(k) numbers
- ["K060983"]
- PMA numbers
- not on file
- Product code
- MQL
- Firm FEI
- 1216677
- Firm city
- Trumbull
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28