FDA Device recall Z-0680-2019
GEM Coupler Forceps, GEM4183C, packaged individually
- FDA Device
- Class II
- ongoing
- Published 2019-01-02
On 2019-01-02 the FDA classified a Class II recall of GEM Coupler Forceps, GEM4183C, packaged individually by Baxter Healthcare, citing potential presence of rust on Coupler Forceps (GEM4183C).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0680-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-11-02 |
| Published | 2019-01-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
GEM Coupler Forceps, GEM4183C, packaged individually.
Reason
Potential presence of rust on Coupler Forceps (GEM4183C).
Identifiers
| code_info | Product Code 5193-06001-010, Lot Number: SP18E129-1307852, Sub-lot Number: 90828, UDI: 00844735002850 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0680-2019%22
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