GEM Microvascular Anastomotic Coupler Devices — Class II medical device recall Z-1685-2020
Terminated recall by Baxter Healthcare Corporation, reported 2020-04-15, distributed nationwide. The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GE
| Recall number | Z-1685-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2020-03-05 |
| Classified | 2020-04-08 |
| Reported by FDA | 2020-04-15 |
| Terminated | 2021-08-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, CA, DE, ES, FR, GB, GR, IL, IT, JP, NL, SA, SE, ZA |
| Quantity | 386 units |
| Reason classes | labeling |
| Lot numbers | SP19J11-1402242, SP19J11-1402246, SP19J11-1402265 |
Product
GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
Reason for recall
The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device
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-1685-2020. 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.