HIGHFDA DEVICE

Medline Recalls Tego Connectors Over High Risk of Fluid Leakage

Official notice
Medline Industries, LPHealth & Personal CareMedical DevicesSKU DYNDA2705 UDI-DI (ea) 10193489468632 UDI-DI (case) 40193489468633 Kit lots 24DBL787 24HBR630 25ABH699 25DBV209 25GBQ405 SKU DYNJ63347A UDI-DI (ea) 10193489278064 UDI-DI (case) 40193489278065 Kit lots 24AMC874 24AME139 24AMH820 24BMF097 24CMF691 24GMB769 24GMK036 24IMC124 24LMA110 25AMJ634 25GMD386 25IMB510 25JMI708

Source-backed recall notice

No product image was available from the source feed.

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

Quick Facts at a Glance

Recall Date
January 8, 2026
Hazard Level
HIGH
Brand
Medline Industries, LP
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, LP
Product type
Tego Connectors
Model numbers
SKU DYNDA2705 UDI-DI (ea) 10193489468632 UDI-DI (case) 40193489468633 Kit lots 24DBL787 24HBR630 25ABH699 25DBV209 25GBQ405 SKU DYNJ63347A UDI-DI (ea) 10193489278064 UDI-DI (case) 40193489278065 Kit lots 24AMC874 24AME139 24AMH820 24BMF097 24CMF691 24GMB769 24GMK036 24IMC124 24LMA110 25AMJ634 25GMD386 25IMB510 25JMI708
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    January 8, 2026

  2. Reported by FDA DEVICE

    March 4, 2026

  3. RecallRadar source check

    March 11, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.

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

Medline's Tego Connectors are used in medical kits for accessing blood products. These connectors are critical for safe and effective medical procedures in a healthcare setting.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may face therapy delays and increased health risks if they do not stop using the affected products. Immediate action is necessary to ensure safety.

Practical Guidance

How to identify if yours is affected

  1. Check the SKU number on your product packaging.
  2. Verify if the lot number matches the recalled lots listed in the recall notice.
  3. Consult with your healthcare provider for additional verification.

Where to find product info

The SKU and lot numbers can usually be found on the product packaging or label attached to the medical kits.

What timeline to expect

Expect a refund or resolution process to take approximately 4-6 weeks after returning the recalled products.

If the manufacturer is unresponsive

  • Document all communications with the company.
  • Contact the FDA or CPSC for further assistance.
  • Consider reaching out to a consumer protection agency.

How to prevent similar issues

  • Always check for recalls before using medical devices.
  • Look for certifications indicating quality and safety standards.
  • Research products and manufacturers before purchase.

Documentation advice

Keep copies of receipts, correspondences, and photos of the defective product as evidence for your records.

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Product Details

The recall includes the Medline Apheresis SubQport Access Kit (SKU DYNDA2705) and the Medline Central Line Insertion Kit (SKU DYNJ63347A). These products were distributed nationwide in the U.S.

Key Facts

  • Recall date: January 8, 2026
  • Total quantity recalled: 1,212 kits
  • High hazard level due to potential fluid leakage
  • Distribution: Nationwide in the U.S.

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 Classification

Product Details

Model Numbers
SKU DYNDA2705 UDI-DI (ea) 10193489468632 UDI-DI (case) 40193489468633 Kit lots 24DBL787 24HBR630 25ABH699 25DBV209 25GBQ405 SKU DYNJ63347A UDI-DI (ea) 10193489278064 UDI-DI (case) 40193489278065 Kit lots 24AMC874 24AME139 24AMH820 24BMF097 24CMF691 24GMB769 24GMK036 24IMC124 24LMA110 25AMJ634 25GMD386 25IMB510 25JMI708
Affected States
ALL
Report Date
March 4, 2026
Recall Status
ACTIVE

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