← FDA ENFORCEMENT
Z-2645-2026Class II

Medela Inc

Recalling firm
Medela Inc
Product type
Device
Status
Ongoing
Report date
2026-07-08
Distribution
US distribution to the following states: AZ, CA, CO, FL, HI, IL, IN, MD, MI, MN, MO, NC, NJ, NY, OR, PA, TX, VA.
Firm state
IL
Product quantity
82900
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
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.

Product description

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

Code / lot info

Lot Code: Item Number ENF060182LD / 101033086; Lot Number 0000747253; Date of Manufacturing 2026-01-16; Expiration Date 2029-01-16; Carton GTIN 20020451101358; Unit GTIN 00020451101354

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.