FDA DevicesClass II
Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE...
Published: April 8, 2026Recall ID: Z-1691-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT
Affected Products
Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98524 |
| Address 1 | 3 Lakes Dr |
| Code info | 1. UDI-DI 10198459016257 (ea) 40198459016258 (case) 2. UDI-DI 10193489860078 (ea) 40193489860079 (case) ALL LOTS |
| Postal code | 60093-2753 |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 9,040 kits |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260213 |
| Initial firm notification | Letter |
| Center classification date | 20260327 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide and the countries of Canada.