Quick Facts at a Glance
- Recall Date
- January 7, 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
- Convenience Kits
- Model numbers
- 1) DYKE1743, UDI-DI: 10193489294606(each), 40193489294607(case), Lot Number: 23KBQ544, 2) DYKE1743, Lot Number: 23JBO193, 3) DYNJ0800934D, UDI-DI: 10193489398885(each) +6 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 7, 2026
Reported by FDA DEVICE
February 25, 2026
RecallRadar source check
March 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
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 convenience kits are pre-packaged surgical supplies used in various medical procedures. Healthcare providers purchase these kits for efficient and sterile operations.
Why This Is Dangerous
The sterilization calibration issues may compromise the sterility of the kits, increasing the risk of infections for patients when used in medical settings.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must stop using these kits to avoid potential infections, which could lead to serious health complications.
Practical Guidance
How to identify if yours is affected
- Check model numbers against the recall list.
- Look for lot numbers listed in the recall notice.
- Verify UDI-DI codes if available.
Where to find product info
Model numbers and lot numbers are typically located on the packaging or labels of the kits.
What timeline to expect
Expect a refund or replacement within 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Document your correspondence with Medline.
- Reach out to the FDA for further assistance if necessary.
- Consider filing a complaint with the CPSC for unresolved issues.
How to prevent similar issues
- Always check for recalls before purchasing medical supplies.
- Look for certifications indicating proper sterilization standards.
- Purchase from reputable suppliers with clear product labeling.
Documentation advice
Keep records of your purchase, including receipts and any correspondence with Medline regarding the recall.
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Product Details
The recalled convenience kits include the following models: DYKE1743, DYNJ0800934D, DYNJ0842873J, DYNJ43415C, DYNJ44066A, DYNJ61978A, DYNJ63542B, DYNJ907452, DYNJC2371G, and PHS853965G. These products were distributed worldwide, including nationwide in the US.
Key Facts
- Recall date: January 7, 2026
- Total units recalled: 3,561
- Class II recall due to high hazard level
- Immediate action required for healthcare providers
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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