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
FDA Recall Z-2645-2026 · Posted 2026-07-01
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Recalling FirmMedela Inc
Recall StatusOpen, Classified
Product CodeFPA
Date Initiated2026-06-05
Product Quantity82900
Reason for Recall
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.
Firm 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.
Root Cause
Process change control
Distribution Pattern
US distribution to the following states: AZ, CA, CO, FL, HI, IL, IN, MD, MI, MN, MO, NC, NJ, NY, OR, PA, TX, VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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