Medela Inc: Set, Administration, Intravascular
Recall Summary Medela is recalling certain ENFit ExSet enteral extension sets (model ENF060182LD) distributed across 18 U.S. states because some units may have incorrect connectors that won't properly attach to ENFit connection ports. This incompatibility could cause delays in delivering nutrition or medication through feeding tubes. The affected product is a medical device used in hospitals and healthcare settings.
- Recalling firm
- Medela Inc
- Product
- Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Product Description: Enteral Extension Set, Length 60 Orange-Striped Minibore Tubing, (Approx. Priming Vol. 2.00 mL), ENFit Component: N/A
- Reason
- May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-05
- Status
- Open, Classified
- Areas affected
- AZ, CA, CO, FL, HI, IL, IN, MD, MI, MN, MO, NJ, ...
- Distribution
- US distribution to the following states: AZ, CA, CO, FL, HI, IL, IN, MD, MI, MN, MO, NC, NJ, NY, OR, PA, TX, VA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/fc9b3dc7-0a46-408a-b338-91bb86411889