Recall Z-1690-2026 ยท PIO Enteral Specific Transition Connectors
Medline Industries, LP
ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
| Date | Mar 27, 2026 (initiated Feb 13, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Process change control |
| Action | On February 13, 2026, the firm notified affected consignees via Urgent Medical Device Recall letters delivered through First Class mail and email. Customers were instructed to destroy all affected ENFit G-Tube connectors and kits that contain the G-Tube connectors. |
| Quantity | 651,789 |
| Distribution | Worldwide - US Nationwide and the countries of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151628 | Medline ENFit Connectors Medline Industries, Inc., Jul 24, 2015 |