HIGHFDA DEVICE

Medline Recalls Dialysis Kits Over Risk of Seal Failure

Official notice
Medline Industries, LPHealth & Personal CareMedical DevicesUDI-DI (ea) 10195327015954 UDI-DI (case) 40195327015955 Kit lots 24IME953 25CMA708

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
Dialysis Convenience Kit
Model numbers
UDI-DI (ea) 10195327015954 UDI-DI (case) 40195327015955 Kit lots 24IME953 25CMA708
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

The dialysis convenience kits are used in medical settings for blood product management in patients undergoing dialysis. They are essential for ensuring the safe delivery and withdrawal of blood products during treatment.

Why This Is Dangerous

The silicone seal defects can cause blockages in fluid paths, meaning healthcare providers may not be able to inject or withdraw necessary blood products, leading to critical delays in patient care.

Industry Context

This recall is not part of a broader industry pattern.

Practical Guidance

How to identify if yours is affected

  1. Check the SKU number DYNDC3167
  2. Verify lot numbers 24IME953 and 25CMA708 on the packaging
  3. Inspect for any visible damage to the silicone seals

Where to find product info

The SKU and lot numbers are typically printed on the product packaging or accompanying documentation.

What timeline to expect

Expect a refund or replacement process to take approximately 4-6 weeks.

If the manufacturer is unresponsive

  • Contact Medline Industries customer service for updates
  • Document all communication attempts
  • Consider filing a complaint with the FDA if unresponsive

How to prevent similar issues

  • Always check for recalls before purchasing medical devices
  • Look for certifications on medical products
  • Consult healthcare providers about product safety

Documentation advice

Keep records of all communications with Medline and any documentation related to the recall, including receipts and product photos.

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Product Details

The recall involves convenience kits containing Tego Connectors, specifically SKU DYNDC3167. The affected lots are 24IME953 and 25CMA708, distributed nationwide.

Key Facts

  • Recalls 150 dialysis convenience kits
  • Hazard due to silicone seal defects
  • Risk of therapy interruption and contamination
  • Affected SKU: DYNDC3167
  • Contact Medline for further instructions

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
UDI-DI (ea) 10195327015954 UDI-DI (case) 40195327015955 Kit lots 24IME953 25CMA708
Affected States
ALL
Report Date
March 4, 2026
Recall Status
ACTIVE

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