Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog... recall (Medela Inc)
Medical deviceClass IIOngoing
Summary: Medela Inc is recalling 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.
What is being recalled
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
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US distribution to the following states: AZ, CA, CO, FL, HI, IL, IN, MD, MI, MN, MO, NC, NJ, NY, OR, PA, TX, VA. (states named: Arizona, California, Colorado, Florida, Hawaii, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Oregon, Pennsylvania, Texas, Virginia)
How to tell if yours is affected
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 to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2645-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 5, 2026 |
| Reported | July 8, 2026 |
| Company | Medela Inc |
| Company location | Mchenry, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 82900 |
More recalls from Medela Inc · all medical device recalls · recalls from June 2026