ENFIT G-TUBE CONNECTOR — Class II medical device recall Z-1690-2026
Ongoing recall by Medline Industries, LP, reported 2026-04-08, distributed nationwide. Connectors were not manufactured to required dimensional specifications and may not form a proper seal with EN
| Recall number | Z-1690-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-02-13 |
| Classified | 2026-03-27 |
| Reported by FDA | 2026-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 651,789 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10888277314719, 40888277314710 |
| Model numbers | ENFIT1010GC |
Product
ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
Reason for recall
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.
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-1690-2026. 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.