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
- PPE Kit
- Model numbers
- 1) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 25IFA006, 2) DYK1011945P, Lot Number: 24GFA027, 3) DYK1011945P, Lot Number: 24FFA115 +4 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
The Medline Convenience Kits PPE Kit is designed for healthcare settings to provide personal protective equipment for staff and patients. Consumers purchase these kits to ensure safety during medical procedures and to prevent the spread of infections.
Why This Is Dangerous
Calibration issues in the sterilization equipment could lead to inadequately sterilized products, risking contamination and infection. This affects the overall safety of the PPE kits, which are critical for infection control in healthcare settings.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers and healthcare providers are urged to stop using the affected PPE kits immediately, as they may not provide the necessary protection against infections. The recall causes inconvenience and potential health risks.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the packaging or product insert.
- Check the lot numbers listed in the recall notice against your product.
- If your product matches, it is affected by the recall.
Where to find product info
Model numbers and lot numbers are typically found on the product packaging or accompanying documentation.
What timeline to expect
Expect a refund or replacement process to take approximately 4-6 weeks from the date of return.
If the manufacturer is unresponsive
- Document all communications with Medline Industries.
- Follow up via email or phone if you do not receive a response within 2 weeks.
- Consider filing a complaint with the CPSC if issues persist.
How to prevent similar issues
- Always verify the sterility of medical devices before use.
- Choose products from trusted manufacturers known for quality control.
- Look for FDA clearance or approval on medical devices.
Documentation advice
Keep copies of your purchase receipts, correspondence with Medline, and any return shipping receipts.
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Product Details
The recalled product is the Medline Convenience Kits PPE Kit, Model Number DYK1011945P. The kits were sold worldwide, including across the United States. The quantity recalled is 7,575 units.
Key Facts
- Recall date: January 7, 2026
- Model Number: DYK1011945P
- Total units recalled: 7,575
- No reported injuries
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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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