HIGHFDA DEVICE

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 ...

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.

MedelaHealth & Personal CareMedical DevicesLot Code: Item Number ENF060182LD / 101033086Lot Number 0000747253Date of Manufacturing 2026-01-16

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
June 5, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
June 5, 2026
Hazard Level
HIGH
Brand
Medela
Geographic Scope
Nationwide (50 states)

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Medela
Model numbers
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
Where affected
Nationwide

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    June 5, 2026

  2. Reported by FDA DEVICE

    July 8, 2026

  3. RecallRadar source check

    July 14, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medela Inc or your healthcare provider for instructions. Notification method: Letter

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Full 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. Reason: 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.. Classification: Class II. Quantity: 82900. 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.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Brand
Model Numbers
Lot Code: Item Number ENF060182LD / 101033086
Lot Number 0000747253
Date of Manufacturing 2026-01-16
Expiration Date 2029-01-16
Carton GTIN 20020451101358
+1 more
Affected States
Nationwide
Report Date
July 8, 2026
Recall Status
ACTIVE