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MEDICAL DEVICE RECALLMODERATE

Medela ENFit Enteral Extension Set

Medela is recalling ENFit Enteral Extension Sets due to incorrect connectors that may cause delivery delays or misconnections.

What to do

Stop using the affected extension sets immediately and contact Medela for further instructions regarding replacement or return.

Posted
Updated
Recall No.
Z-2645-2026
Agency
Firm
Medela Inc
Recall ID
99100
Status
ONGOING

Why it was recalled

Medela is recalling the ENFit Enteral Extension Set due to incorrect connectors that are incompatible with ENFit connections. This defect may cause misconnections or delays in the delivery of enteral nutritional fluids or oral medications.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

UPC
101033086, 0000747253, 20020451101358, 00020451101354
Recall #
Z-2645-2026

Where it was sold

Distributed in Arizona, California, Colorado, Florida, Hawaii, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Oregon, Pennsylvania, Texas, and Virginia.

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Editorial summary by Recall Canary · last updated 2026-07-02 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification