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 Convenience Kits
- Model numbers
- 1) CDS820080N, UDI-DI: 10195327278014(each), 40195327278015(case), Lot Number: 23IMB818, 2) CDS983523G, UDI-DI: 10195327283681(each), 40195327283682(case), Lot Number: 23IBS984 +8 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 designed for surgical procedures, including C-sections. They contain various sterile components necessary for safe surgical practices.
Why This Is Dangerous
The calibration issues with sterilization equipment could lead to compromised sterility, increasing the risk of infections during surgical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may cause delays in surgical procedures if hospitals need to replace affected kits, creating both logistical challenges and potential health risks.
Practical Guidance
How to identify if yours is affected
- Check the model number of your Medline Convenience Kit against the recalled list.
- Look for the UDI-DI and lot number on the packaging.
- Verify if your product falls within the specified quantities and dates.
Where to find product info
You can find the serial numbers, UDI-DI, and lot numbers printed on the product packaging and labels.
What timeline to expect
Expect a timeline of 4-6 weeks for refund processing once the return is initiated.
If the manufacturer is unresponsive
- Document all communication attempts with Medline.
- Reach out to the FDA for assistance if necessary.
How to prevent similar issues
- Ensure future purchases include verification of sterilization certifications.
- Research the manufacturer's quality controls before purchasing medical devices.
- Always check for recalls on medical products before use.
Documentation advice
Keep receipts, correspondence with Medline, and any documentation regarding your product return for your records.
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Product Details
The recall affects 36 models of Medline Convenience Kits, including C-SECTION PACK models CDS820080N and CDS983523G. These kits were distributed worldwide, including across the U.S., and sold to hospitals and healthcare providers.
Key Facts
- Recall date: January 7, 2026
- Total units recalled: 4,525
- Issue: Sterilization calibration problems
- Action required: Stop using immediately
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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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