GEM Coupler Forceps — Class II medical device recall Z-0680-2019
Ongoing recall by Baxter Healthcare Corporation, reported 2019-01-02, distributed nationwide. Potential presence of rust on Coupler Forceps (GEM4183C).
| Recall number | Z-0680-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2018-11-02 |
| Classified | 2018-12-22 |
| Reported by FDA | 2019-01-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, DE, GB, JP, ZA |
| Quantity | 123 devices |
| UPC / GTIN / UDI-DI | 00844735002850 |
| Lot numbers | 90828, SP18E129-1307852 |
Product
GEM Coupler Forceps, GEM4183C, packaged individually.
Reason for recall
Potential presence of rust on Coupler Forceps (GEM4183C).
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-0680-2019. 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.