FDA Medical Device Recalls (openFDA)
CooperSurgical, Inc.: Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
- Recall number
- Z-1348-2023
- Recalling firm
- CooperSurgical, Inc.
- Product
- Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
- Status
- Open, Classified
- Initiated
- 2023-02-13
- Posted
- 2023-04-06
- Terminated
- not on file
- Reason
- It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and development.
- Root cause
- Labeling Change Control
- Action
- An URGENT: VOLUNTARY MEDIA RECALL dated 1/26/23 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 Please complete and return the appropriate enclosed Acknowledgment Form (even if you do not have the specific lot remaining in stock) to initiate our recall return process. Credit will be applied to your account to reorder replacement product, as per our recall process, with no additional cost to you or your facilities. o The form can be returned to CooperSurgical via email at Recall@coopersurgical.com or via fax at +1.203.601.9870 Please feel free to contact your local account manager or contact us at +1-203-601-5200 Monday Friday 09:00 17:00 EST, and follow the phone prompt to enter the ext. 3300 or via email at Recall@coopersurgical.com. If affected Product has been distributed to customers, please select one of the following options: " I have identified and notified all customers to whom the affected Product may have been distributed. " I am providing a list of all customers to whom affected Product may have been distributed along with their contact information.
- Quantity
- 190 units
- Distribution
- Worldwide - US Nationwide distribution in the states of NY, UT and the countries of Argentina, Belgium, Bulgaria, Ecuador, France, Germany, Hong Kong, Italy, Malaysia, Mexico, Peru, Singapore, Spain, Switzerland, Thailand, Turkey, the United Kingdom.
- Lot, serial or model codes
- UDI-DI: 00815965020433; LOT 221118-010694
- 510(k) numbers
- K142991
- 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