413recalls · last 30 days
40CPSC · last 30 days
304FDA · last 30 days
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3,489in 180-day window

Medela Inc recalls

RecallSweep is tracking 1 recall notice naming Medela Inc in the last 180 days, issued by FDA. The most recent is dated July 8, 2026. They cover Medical Devices. Hazards cited include Chemical & Lead.

This page lists what the issuing agencies published. It is not a statement about Medela Inc beyond those notices — open each official notice for the authoritative detail.

Recall notices naming Medela Inc

1 recall.

FDA Class II Medical Devices ⚠ Chemical & Lead

Medela Inc: Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Product De…

Affected quantity: 82900

Hazard
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.

Details
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.. Recall #Z-2645-2026, initiated 20260605. Voluntary: Firm initiated.

Products affected
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

Recall status
Ongoing

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