Recall Z-2645-2026 ยท FPA Set, Administration, Intravascular
Medela Inc
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
| Date | Jul 1, 2026 (initiated Jun 5, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Process change control |
| Action | On June 5, 2026, the firm notified customers via letters titled "URGENT Medical Device Recall." Customers were instructed to quarantine affected product lots, dispose of products, and complete and return a customer response form. Upon receipt of the completed response form, Medela will contact the customer to replace product. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K895367 | INTRAVENOUS EXTENSION SET Medical Product Specialists, Oct 6, 1989 |