Data Foundry

Medical device recalls 2023

Global Total LP single step medium — Class II medical device recall Z-1348-2023

Ongoing recall by CooperSurgical, Inc., reported 2023-04-12, distributed nationwide. It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global

Recall numberZ-1348-2023
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCooperSurgical, Inc., Trumbull, CT, United States
Recall initiated2023-02-13
Classified2023-04-06
Reported by FDA2023-04-12
DistributedNationwide (US)
Countries outside the USAR, BE, BG, CH, DE, EC, ES, FR, GB, HK, IT, MX, MY, PE, SG, TH, TR
Quantity190 units
UPC / GTIN / UDI-DI00815965020433
Lot numbers221118-010694

Product

Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1348-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.