Enteral Extension Set Recall: Medela ENFit ExSet 60
Announced 2026-07-08 · FDA
Medela Inc is recalling ENFit ExSet Strl 60 enteral extension sets due to potential incorrect connectors that may not attach or could misconnect to ENFit connections, making them incompatible. The issue could cause a slight delay in delivery of enteral nutritional fluids or oral medications. About 82,900 units were distributed in the United States to AZ, CA, CO, FL, HI, IL, IN, MD, MI, MN, MO, NC, NJ, NY, OR, PA, TX and VA; Lot 0000747253 manufactured 2026-01-16 with expiration 2029-01-16.
| Brand | 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. |
| Severity | moderate |
| Units affected | 82900 |
| 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. |
| Agency | FDA |
| Recall / campaign no. | Lot Code: Item Number ENF060182LD / 101033086; Lot Number 0000747253; Date of Manufacturing 2026-01-16; Expiration Date 2029-01-16; Carton GTIN 20020451101358; Unit GTIN 00020451101354 |
WHAT YOU SHOULD DO
- Stop using the affected ENFit ExSet Strl 60 units immediately.
- Check packaging for Lot 0000747253 (ENF060182LD / 101033086) and expiration date 2029-01-16 to determine if your product is affected.
- Contact Medela or your supplier for guidance on replacement, return, or disposal.
- If used in a medical setting, consult your healthcare professional for next steps.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.