Enteral Specific Transition Connectors
FDA adverse event reports and recall history for enteral specific transition connectors (product code PIO), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 401
- Deaths
- 2
- Injuries
- 6
- Malfunctions
- 389
Reports per year
Source: FDA adverse event reports by year received, 2015–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-03-27Open, ClassifiedProcess change control
ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
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.
- 2026-03-27Open, ClassifiedProcess change control
Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT
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.
- TerminatedLabeling Change Control
AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075
The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.
Monitor enteral specific transition connectors automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.