Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2645-2026 — 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

U.S. FDA — Device Enforcement · United States · 2026-06-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2645-2026
Date of alert
2026-06-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medela Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
101033086
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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