HIGH

Medline Recalls Dialysis Kits Over Risk of Seal Failure

Medline Industries recalled 150 dialysis convenience kits on January 8, 2026, due to silicone seal defects. Affected kits may obstruct fluid paths and risk exposure to biological contaminants.

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

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

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

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.

Real-World Impact

Patients and providers need to stop using these kits immediately due to potential health risks. The risk of exposure to contaminants or interrupted therapy creates urgency for action.

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.

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
View Original Recall on FDA - Medical Devices

Browse More Recalls

More from FDA_DEVICEHealth & Personal CareMedical Devices

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

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

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

Product Classification

Product TypeDialysis Convenience Kit
Sold At
Multiple Retailers

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

Related Recalls

Health & Personal Care
HIGH

Medline Angiography Kit Recall: 3,120 Medical Convenience Kits With NAMIC Adaptor May Disconnect (Z-

Medline Industries, LP recalls 3,120 medical convenience kits worldwide due to a risk the syringe rotating adaptor may unwind during use. The issue can create a loose connection or complete disconnection between the syringe and manifold. The recall was issued on February 27, 2026 and is active. Customers should stop using the kit and follow manufacturer instructions for recall notices.

Medline Industries, LP
Medline Industries,
Read more
Health & Personal Care
HIGH

Medline NAMIC Angiographic Rotating Adaptor Syringes Recalled in Class I Action for 79,843 Units

Medline Industries issued a Class I recall for 79,843 medical convenience kits containing NAMIC Angiographic Rotating Adaptor syringes. The action covers worldwide distribution including the US and PR. The risk is a syringe adaptor unwinding during use, which may cause a loose connection or disconnection with the manifold. Stop using the device immediately and follow recall instructions.

Medline Industries, LP
Medline Industries,
Read more
Health & Personal Care
HIGH

Medline NAMIC Angiographic Syringe Recall Affects 17,902 Kits Worldwide (2026)

Medline Industries, LP recalls 17,902 medical convenience kits worldwide after post-market surveillance found a potential risk of the syringe rotating adaptor unwinding. The recall covers NAMIC Angiographic RA control syringes labeled in 10 Medline SKUs. Healthcare providers should stop use immediately and follow recall instructions.

Medline Industries, LP
Medline Industries,
Read more
Health & Personal Care
HIGH

Medline NAMIC Angiographic Rotating Adaptor Syringe Recall Affects 762 Units Worldwide (2026)

Medline Industries, LP recalls 762 medical convenience kits containing NAMIC Angiographic Rotating Adaptor syringes sold worldwide, including the U.S., PR, Canada, and several international markets. The recall cites a potential risk that the syringe rotating adaptor may unwind during use, creating a loose connection or disconnect between the syringe and the manifold. Stop using the device and seek

Medline Industries, LP
Medline Industries,
Read more
Health & Personal Care
HIGH

Medline NAMIC RA Syringe Adaptor Recall Aims to Prevent Connection Failures in 60 Kits (2026)

Medline Industries, LP recalled 60 medical convenience kits worldwide due to a potential rotating adaptor unwinding in NAMIC Angiographic RA control syringes. The issue may cause a loose connection or disconnection between the syringe and manifold. Healthcare providers should stop using the device and follow the manufacturer’s recall instructions.

Medline Industries, LP
Medline Industries,
Read more
Health & Personal Care
HIGH

Medline NAMIC Angiographic RA Syringes Recalled in 1698 Kits for Unwinding Adaptor Risk (2026)

Medline Industries, LP recalls 1,698 medical convenience kits worldwide over a potential unwind of the NAMIC Angiographic Rotating Adaptor during use. The risk could cause a loose connection or complete disconnection between the syringe and manifold. Healthcare providers and patients should stop using the affected kits immediately and follow recall instructions.

Medline Industries, LP
Medline Industries,
Read more