FDA recall, , Moderate risk
Medela ENFit Enteral Extension Sets
The ENFit ExSet Strl 60 2.0ml PV 1ct EN may have incorrect connectors, causing misconnection and delivery delays.
Summary by Recall Canary from the FDA notice
What happened
Medela Inc of Mchenry, Illinois began a recall on June 5, 2026 of the Medela ENFit ExSet Strl 60 2.0ml PV 1ct EN, an enteral extension set with 60 orange-striped minibore tubing. The product may contain incorrect connectors and will not attach or misconnect to ENFit connections, causing incompatibility and a slight delay in delivery of enteral nutritional fluids or oral medication.
The FDA added the recall to its Enforcement Report and classified it on July 1, 2026, with the weekly report on July 8, 2026, covering states including Arizona, California, Colorado, Florida, Hawaii, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Oregon, Pennsylvania, Texas and Virginia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and lot code listed under your product.
ENFit ExSet Strl 60 2.0ml PV 1ct EN
- Model number
- ENF060182LD
- Lot code
- 101033086
- 0000747253
Recall details
- Company began the recall
- Sold in
- 18 states
- Company
- Medela IncMchenry, Illinois
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99100
- Recall number
- Z-2645-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
