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) DYKM1801B, UDI-DI: 10653160360421(each), 00653160360424(case), Lot Number: 2024100790, 2) DYKM1776, UDI-DI: 10888277733794(each), 20888277733791(case), Lot Number: 2025013190 +12 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 designed for surgical procedures and include various tools and devices necessary for operations. Healthcare providers use these kits to ensure sterile conditions during surgeries and procedures.
Why This Is Dangerous
Calibration issues with sterilization equipment may compromise the sterility of the kits, potentially exposing patients to infection risks. Each kit was exposed to validated sterilization cycles, but the calibration errors raise concerns about their effectiveness.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers who rely on these kits. It may lead to delays in surgical procedures and requires immediate action to ensure patient safety.
Practical Guidance
How to identify if yours is affected
- Check the model number on the product packaging.
- Confirm if your product matches any of the recalled models listed in the recall notice.
- Look for any notifications from Medline in your mail or email.
Where to find product info
Model numbers can be found on the packaging or the product itself, typically near the barcode or on an attached label.
What timeline to expect
Expect a timeline of approximately 4-6 weeks for processing refunds or replacements after returning the product.
If the manufacturer is unresponsive
- Contact Medline's customer service again for follow-up.
- Keep a record of your communication attempts.
- Consider filing a complaint with the FDA if you do not receive a response.
How to prevent similar issues
- Always check for the latest recalls before using medical devices.
- Look for products with clear labeling and safety certifications.
- Consult with healthcare providers about the safety of medical products.
Documentation advice
Keep records of your purchase, any correspondence with Medline, and photographs of the product for your records.
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Product Details
The recall includes the following models: DYKM1801B, DYKM1776, DYKM1765A, DYKM1796A, DYKM1756A, among others. The products were distributed worldwide, including the US. No pricing information was provided.
Key Facts
- Recall date: January 7, 2026
- Quantity recalled: 1,496 units
- Class II recall
- Potential sterility risks identified
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Safety Guide
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