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
- Dialysis Dressing Change Kit
- Model numbers
- Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 UDI-DI (ea) 10193489111538 UDI-DI (case) 20193489111535 Kit lots 2024052090 2024072690 2024100390 2024121290 2025020490 2025041590 2025062790 2025090890 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 UDI-DI (ea) 10889942723508 UDI-DI (case) 40889942723509 Kit lots 2024051690 2024073190 2024092490 2024121190 2025020790 2025032790 2025052990 EBSI1596 UDI-DI (ea) 10653160357162 UDI-DI (case) 00653160357165 Kit lots 2024070190 2024082390 2024102390 2024121790 2025031090 2025040190 2025052790 2025072890 EBSI1781 UDI-DI (ea) 10653160379638 UDI-DI (case) 00653160379631 Kit lots 2024100490 2024123090 EBSI1812 UDI-DI (ea) 10653160386735 UDI-DI (case) 00653160386738 Kit lots 2025032190 2025052990 Centurion DIALYSIS/PHERESUS CVC DRSG CHANGE KIT SKU DT22630 UDI-DI (ea) 10653160345343 UDI-DI (case) 00653160345346 Kit lots 2024050680 2024072980 2024090380 2024111290 2024121190 2025032890 2025061790 2025072390 Medline DIALYSIS/PHERESIS DRESSING CHANGE KIT SKU EBSI1470 UDI-DI (ea) 10193489199307 UDI-DI (case) 20193489199304 Kit lots 2024052080 2024070880 2024110490 2025010290 2025022090 2025030390 2025040990 2025072990 Centurion VASCATH DRESSING CHANGE TRAY SKU DT22845 UDI-DI (ea) 10653160355151 UDI-DI (case) 00653160355154 Kit lots 2024060790 2024080790 2024100990 2024112590 2025042490 2025082090
- 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
The Medline dialysis dressing change kits are essential for maintaining the sterility and safety of dialysis procedures. Healthcare providers use these kits to change dressings on patients undergoing dialysis treatment.
Why This Is Dangerous
The hazard arises from potential defects in the silicone seal of Tego Connectors, which can lead to blocked fluid paths. This blockage can prevent effective blood withdrawal or injection, posing serious risks to patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Practical Guidance
How to identify if yours is affected
- Check the SKU number on your dialysis dressing kit packaging.
- Look for any signs of damage to the silicone seals of the Tego Connectors.
- Verify if your kit is included in the recall list provided by Medline.
Where to find product info
SKU numbers can usually be found on the product packaging or label. For UDI numbers, check the product's box or case packaging.
What timeline to expect
Expect a refund or replacement process to take approximately 4-6 weeks after the recalled product is returned.
If the manufacturer is unresponsive
- Keep a record of your communications with Medline Industries.
- Consider filing a complaint with the FDA if you do not receive a response.
How to prevent similar issues
- Look for medical devices with clear safety certifications.
- Consult healthcare professionals for recommended brands and products.
- Read reviews and reports on medical devices before purchasing.
Documentation advice
Document all communications with the manufacturer and keep copies of any receipts or return shipping confirmations.
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Product Details
The recall includes several models of dialysis dressing change kits, specifically SKU EBSI1498, EBSI1107, EBSI1596, EBSI1781, EBSI1812, DT22630, EBSI1470, and DT22845. These kits were distributed nationwide in the U.S. and sold at multiple retailers.
Key Facts
- Recall date: January 8, 2026
- Affected quantity: 31,848 kits
- Class II recall classification
- Immediate action required
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