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) CDS982407N, UDI-DI: 10193489683004(each), 40193489683005(case), Lot Number: 21DBO201, 2) CDS982407N, Lot Number: 21CBD150, 3) CDS985431K, UDI-DI: 10195327451295(each) +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 used in various surgical procedures, providing essential tools and materials for healthcare providers. These kits are crucial for ensuring sterile environments during surgeries, making them vital in medical settings.
Why This Is Dangerous
The calibration issues with sterilization equipment mean that the kits may not have been properly sterilized, which increases the risk of infections during procedures. This defect compromises the integrity of the surgical kits and their safety for use.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects a wide range of surgical kits that could potentially compromise patient safety. Immediate action is necessary to prevent risks associated with infections, leading to healthcare challenges.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the kit packaging.
- Check the list provided in the recall notice to see if your model is included.
- Verify the lot number against the recalled lot numbers.
Where to find product info
Model numbers and lot numbers can be found on the packaging of the kits or on the product labels.
What timeline to expect
Expect a timeline of 4-6 weeks for refund processing after returning the recalled kits.
If the manufacturer is unresponsive
- Contact Medline Industries directly at the provided phone number.
- Follow up with your healthcare provider for assistance.
How to prevent similar issues
- Ensure all medical devices have current sterilization certifications before use.
- Purchase from reputable suppliers to avoid similar issues in the future.
- Stay updated on product recalls through health safety websites.
Documentation advice
Keep all correspondence regarding the recall, including receipts and return confirmations. Document any adverse effects experienced after using the kits.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recall includes 31 models of Medline Convenience Kits, such as the BAP North Robotic Surgery CDS (Model Number: CDS982407N) and various D&C Packs. These products were distributed worldwide, including the U.S., and were sold under Medline Industries, LP.
Key Facts
- Recall initiated on January 7, 2026
- High risk due to potential sterility issues
- No injuries reported yet
- Immediate action required to stop use
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.