BIOPSY MEDIUM 10ML — Class II medical device recall Z-1044-2023
Ongoing recall by CooperSurgical, Inc., reported 2023-02-08, distributed in GA. The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Produc
| Recall number | Z-1044-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2022-12-15 |
| Classified | 2023-01-31 |
| Reported by FDA | 2023-02-08 |
| Distributed | GA |
| Countries outside the US | AE, BE, BG, BH, EG, ES, FR, GR, HK, IL, IQ, IR, JO, JP, KW, LB, NG, OM, PK, PL, SA, SI, TH, TR |
| Quantity | 489 units |
| Reason classes | specification failure |
| Lot numbers | 220506-006557 |
Product
BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)
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.
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-1044-2023. 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.