FDA Device recall Z-1690-2026
ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
- FDA Device
- Class II
- ongoing
- Published 2026-04-08
On 2026-04-08 the FDA classified a Class II recall of ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC by Medline Industries, citing connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1690-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-13 |
| Published | 2026-04-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
Reason
Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.
Identifiers
| code_info | UDI-DI 10888277314719 (ea) 40888277314710(case) All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1690-2026%22
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