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) DYKM2326, UDI-DI: 10198459565748(each), 40198459565749(case), Lot Number: 25KMF765, 2) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 24ABK386 +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 used in medical settings for various procedures including obstetrics and gynecology. They typically contain essential tools and supplies needed for safe medical practices.
Why This Is Dangerous
Calibration issues with sterilization equipment may lead to non-sterile products, increasing the risk of infection or other complications for patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall poses a serious health risk, particularly for patients undergoing medical procedures. Immediate action is required to prevent potential infections.
Practical Guidance
How to identify if yours is affected
- Check the model number against the recall list.
- Verify the lot number on the packaging.
- Consult with your healthcare provider if unsure.
Where to find product info
Model numbers and lot numbers can usually be found on the packaging or the product label.
What timeline to expect
Expect a refund or replacement processing time of approximately 4 to 6 weeks.
If the manufacturer is unresponsive
- Document all communication attempts with Medline.
- Consider reaching out to the FDA if you receive no response.
How to prevent similar issues
- Look for FDA-approved products in the future.
- Ensure products have visible sterilization certifications.
- Ask healthcare providers about the sterility of medical kits before use.
Documentation advice
Keep all receipts, correspondence, and any other relevant information regarding your purchase and recall.
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Product Details
The recall includes multiple models of Medline convenience kits, including OB KIT (DYKM2326) and various vaginal delivery packs. These kits were sold worldwide, with distribution across the U.S. since their manufacturing.
Key Facts
- Recall date: January 7, 2026
- Total quantity recalled: 27,320 units
- Risk level: High
- Immediate action required
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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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