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Lower risk Medical device recall · FDA · Published June 5, 2026

Medela ENFit ExSet Strl 60 2.0ml PV 1ct EN: Incompatible Connectors Risk

Medela recalls ENFit ExSet Strl 60 2.0ml PV 1ct EN due to incompatible connectors that may cause delays in feeding or medication delivery. Affected units have model ENF060182LD or 101033086.

🇺🇸 FDA recall #Z-2645-2026Medical deviceMedela ›
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Contact the company

Recalling firmMedela Inc1101 Corporate Dr · Mchenry, IL 60050-7006
✎ GovInfoNow plain-language explainer

Medela is recalling its ENFit ExSet Strl 60 2.0ml PV 1ct EN product because it may have incorrect connectors that don't attach properly. This could cause delays in delivering enteral nutrition or oral medication to patients. Read more at govinfonow.com/recall/49039-medela-enfit-exset-strl-60-2-0ml-pv-1ct-en.

Source Summary by GovInfoNow · govinfonow.com/recall/49039-medela-enfit-exset-strl-60-2-0ml-pv-1ct-en · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2645-2026

Cite this page

“Medela ENFit ExSet Strl 60 2.0ml PV 1ct EN: Incompatible Connectors Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49039-medela-enfit-exset-strl-60-2-0ml-pv-1ct-en. Based on FDA recall #Z-2645-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2645-2026%22&limit=1).

The FDA announced on June 5, 2026, that Medela Inc is voluntarily recalling its ENFit ExSet Strl 60 enteral extension sets due to potential connector incompatibility. Owners should stop using the product immediately.

How to tell if you have it

  • Brand: Medela
  • Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN
  • Model/Catalog Number: ENF060182LD / 101033086
  • Lot Number: 0000747253
  • Date of Manufacturing: 2026-01-16
  • Expiration Date: 2029-01-16
  • UPC: 00020451101354
  • Carton GTIN: 20020451101358

The hazard

The devices may contain incorrect connectors that will not attach or misconnect to ENFit connections, rendering them incompatible. This issue could lead to a slight delay in the delivery of enteral nutritional fluids or oral medication.

Context

GovInfoNow's records show Medela Inc has issued three other recalls since February 7, 2018, including a December 2, 2019 recall for Invia Foam Dressing Kits with potential sterile packaging holes and a December 5, 2018 recall for Breast Milk Transfer Lids with compromised packaging. Other recent recalls of similar products include Medline ENFIT G-Tube Connectors recalled on February 13, 2026, for potential leaks, and two Avanos Medical PEG Kit recalls announced on April 30, 2026, involving lidocaine risks.

How to tell if you have this one

Check for model numbers ENF060182LD or 101033086 on the product packaging. The product was manufactured on January 16, 2026, and expires January 16, 2029.

  • Brand
    Medela
  • Product
    Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Model

    Look for model numbers ENF060182LD or 101033086 on the packaging or product label.

Where it went and when

Where it was distributed

Distributed in 18 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: not listedOHPennsylvania: yesPANew Jersey: yesNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: yesCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: not listedWVVirginia: yesVAMaryland: yesMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Colorado, Florida, Hawaii, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York, North Carolina, Oregon, Pennsylvania, Texas, Virginia.

Recall timeline

FDA published this recall 33 days after the firm started it.

1. Firm started the recall: Jun 5, 202612. FDA classified it Class II: Jul 1, 202623. Published in FDA’s Enforcement Report: Jul 8, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2645-2026 (June 5, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2645-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA