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
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 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
- Medical Kits
- Model numbers
- IR PACK UDI-DI (ea) 10195327621780 UDI-DI (case) 40195327621781 Kit lots 24BBP627 24DBO029 24FBI148 24JBA858 24KBD925 24LBG978 25ABQ002 25EBV162, NO CATHETER DIALYSIS INSERTION UDI-DI (ea) 10195327675219 UDI-DI (case) 40195327675210 Kit Lots 24EBM915 24GBC287
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 8, 2026
Reported by FDA DEVICE
March 4, 2026
RecallRadar source check
March 11, 2026
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 medical kits are used in various healthcare settings for procedures involving fluid management. They are essential for safe and effective medical treatments, making them critical for healthcare providers.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face delays in critical medical treatments due to the potential hazards associated with these kits. Immediate action is necessary to prevent health risks.
Practical Guidance
How to identify if yours is affected
- Check the SKU numbers against the recall notice.
- Verify the lot numbers listed in the recall.
- Inspect the Tego Connectors for any visible damage.
Where to find product info
SKU and lot numbers can typically be found on the product packaging or accompanying documentation.
What timeline to expect
Expect a refund or replacement to be processed within 4 to 6 weeks after returning the product.
If the manufacturer is unresponsive
- Contact Medline Industries directly for assistance.
- Document all communication attempts and seek further support if needed.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Look for products with verified safety certifications.
- Consult with healthcare providers about product safety before purchasing.
Documentation advice
Keep all receipts, correspondence with Medline, and photos of the affected product for your records.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recall affects Medline IR Pack (SKU DYNJ67205C) and Medline NO CATHETER DIALYSIS INSERTION (SKU CVI5200). These kits were distributed nationwide in the United States.
Key Facts
- 516 medical kits recalled
- Affected models include IR Pack and NO CATHETER DIALYSIS INSERTION
- Silicone seal issues may cause leakage or therapy delays
- Immediate action required: stop using the devices
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.