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
- Surgical Kits
- Model numbers
- 1) DYKMBNDL84A, UDI-DI: 10195327240486(each), 40195327240487(case), Lot Number: 23ABK216, 2) DYKMBNDL84A, Lot Number: 22IBU924, 3) DYKMBNDL84A, Lot Number: 22IBQ267 +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 medical kits containing instruments and supplies for surgical procedures. Healthcare providers purchase these kits to ensure they have all necessary tools for specific surgeries.
Why This Is Dangerous
Calibration issues with the sterilization equipment may compromise the sterility of the kits, increasing the risk of infection during surgical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers face possible infection risks, highlighting the urgency to stop using these kits.
Practical Guidance
How to identify if yours is affected
- Check the model number on the packaging or product label.
- Verify if your kit matches any of the recalled models listed in the recall notice.
- Contact your healthcare provider if unsure about the kit's status.
Where to find product info
Model numbers and lot numbers can typically be found on the product box or label attached to the kit.
What timeline to expect
Expect 4-6 weeks for the refund processing after returning the product.
If the manufacturer is unresponsive
- Document your attempts to contact the company.
- Consider following up via email or a secondary phone call.
- If no response, escalate the issue to consumer protection agencies.
How to prevent similar issues
- Ensure future purchases are from reputable manufacturers with strong safety records.
- Ask about the sterilization methods used for medical devices before purchasing.
- Check for recalls on medical devices regularly.
Documentation advice
Keep a record of all communications with the manufacturer, including emails and phone call details.
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Product Details
The recall affects the following kits: KIT SURG ONC EXCISION BREAST (Model DYKMBNDL84A), KIT SURG ONC EXPLORATORY LAP (Model DYKMBNDL87A), CT BIOPSY TRAY (Model DYNDH1143C), and several others. The products were distributed worldwide and sold in the U.S. since their manufacturing.
Key Facts
- Recall date: January 7, 2026
- Quantity: 2,740 units affected
- Class II recall
- Immediate action required from users
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Safety Guide
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