FDA-Device2026-07-08Class IIMISBRANDING
Medela ENFit ExSet enteral extension set recalled for incompatible connectors
What this means
Some Medela ENFit ExSet enteral extension sets contain incorrect connectors that may not attach properly to ENFit connections. This incompatibility could cause a slight delay in delivering nutrition or medication through the feeding tube.
- Check if you have lot number 0000747253 (manufactured 2026-01-16) of Medela ENFit ExSet Strl 60 (model ENF060182LD).
- Contact your healthcare provider or Medela if you have this product.
- Do not discard the product; follow your provider's instructions for safe replacement or return.
The agency's original wording
Hazard
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.
Intended for
All ages
Illnesses reported
None reported
Sold states
US distribution to the following states: AZ, CA, CO, FL, HI, IL, IN, MD, MI, MN, MO, NC, NJ, NY, OR, PA, TX, VA.
Affected count
82900
Manufactured in
1101 Corporate Dr, N/A, Mchenry, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2645-2026Want us to check the next one for you?
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