global Medium — Class II medical device recall Z-1089-2024
Ongoing recall by CooperSurgical, Inc., reported 2024-02-21, distributed nationwide. The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may
| Recall number | Z-1089-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2023-12-20 |
| Classified | 2024-02-14 |
| Reported by FDA | 2024-02-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, BE, BR, CA, DE, DK, EE, ES, FR, GB, GR, HK, JO, JP, MX, NL, NZ, PL, SA, TH, TR, TW |
| UPC / GTIN / UDI-DI | 00815965020044, 00815965020051, 00815965020068 |
| Lot numbers | 231020-018741, 231020-018742, 231020-018743, LGGG-050, LGGG-100 |
| Model numbers | LGGG-020 |
Product
global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.
Reason for recall
The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage.
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-1089-2024. 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.