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Medline ENFIT G-Tube Connector ENFIT1010GC Recalled for Leakage Risk (651,789 Units, 2026)

Medline Industries recalled 651,789 ENFIT G-TUBE connectors (ENFIT1010GC) sold worldwide, including the United States and Canada. The connectors were not manufactured to required dimensional specifications and may not seal properly with ENFit-style devices, which could lead to leakage. Healthcare facilities and patients should stop using this device immediately and follow recall instructions from

Official notice
Medline IndustriesHealth & Personal CareMedical DevicesUDI-DI 10888277314719 (ea) 40888277314710(case) All Lots

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
February 13, 2026
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
February 13, 2026
Hazard Level
HIGH
Brand
Medline Industries
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

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
Medline Industries
Product type
ENFIT G-Tube Connector
Model numbers
UDI-DI 10888277314719 (ea) 40888277314710(case) All Lots
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    February 13, 2026

  2. Reported by FDA DEVICE

    April 8, 2026

  3. RecallRadar source check

    April 15, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.

What You Should Do

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

About This Product

These connectors are used to attach ENFit-compatible G-tube feeding devices in clinical settings. They facilitate enteral feeding in patients with GI access.

Why This Is Dangerous

If the connector does not seal properly, fluids can leak, potentially delaying care and causing infection or patient discomfort. Over-tightening to stop leaks can worsen outcomes.

Industry Context

This recall is not described as part of a broader industry pattern in the provided data.

Real-World Impact

Hospitals and clinics may need to quarantine affected inventory, notify staff, and coordinate with Medline for replacements or refunds. The issue could affect patient care timelines.

Practical Guidance

How to identify if yours is affected

  1. Identify product as ENFIT G-TUBE CONNECTOR ENFIT1010GC.
  2. Confirm quantity recalled: 651,789 units.
  3. Refer to the recall letter for specific instructions.

Where to find product info

Recall letter from Medline and the FDA enforcement page linked in the recall notice.

What timeline to expect

Not specified in the recall notice.

If the manufacturer is unresponsive

  • Escalate with hospital compliance or medical device safety office.
  • File a complaint with the appropriate regulatory body if the vendor is unresponsive.

How to prevent similar issues

  • Verify ENFit components are from reputable manufacturers and compliant with ENFit standards.
  • Implement a routine check of ENFit connectors during device inventory audits.

Documentation advice

Document recall references, catalog numbers, lot numbers, dates, and all correspondence with Medline.

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Product Details

Item: ENFIT G-TUBE CONNECTOR ENFIT1010GC. Distribution: Worldwide, including US and Canada. Class II recall. Quantity: 651,789 units. Model/UDI: UDI-DI 10888277314719 (ea) 40888277314710 (case) All Lots. Brand: Medline Industries, LP.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 651,789 units recalled worldwide
  • Recall issued 2026-02-13; status ACTIVE
  • Hazard: leakage from ENFit-G tube connector due to dimensional nonconformity
  • Risk: delayed care, fluid loss, potential infection with over-tightening
  • Remedy: stop using immediately; follow recall letter instructions; contact Medline or provider for r

Safety Guide

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

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
UDI-DI 10888277314719 (ea) 40888277314710(case) All Lots
Affected States
ALL
Report Date
April 8, 2026
Recall Status
ACTIVE

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