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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.

Recalled
Listed
Updated
Recall No.
Z-2645-2026
Agency
FDA
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.

Medela ENFit ExSet Strl 60 2.0ml PV 1ct EN

Lot code
ENF060182LD, 101033086, 0000747253
UDI-DI
101033086, 0000747253, 20020451101358, 00020451101354
Model/Catalog number
ENF060182LD / 101033086

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.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other Device Defect recalls

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