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) CDS982893I, UDI-DI: 10889942208050(each), 40889942208051(case), Lot Number: 24IBO240, 2) CDS983300J, UDI-DI: 10193489425048(each), 40193489425049(case), Lot Number: 21CDB781 +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 surgical kits are designed for various medical procedures, primarily in gynecology and urology. These kits include essential tools and instruments needed for surgeries, ensuring that healthcare providers have everything required for safe operations.
Why This Is Dangerous
Calibration issues in the sterilization equipment could lead to a failure in achieving the expected sterility assurance level (SAL) for the kits. This failure increases the risk of infection or complications during surgical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects patient safety and may lead to delays in scheduled surgeries while healthcare providers identify and remove affected kits from use.
Practical Guidance
How to identify if yours is affected
- Locate the model number on your surgical kit packaging.
- Compare the model number against the recalled models list provided by Medline.
- Contact your healthcare provider if you are unsure about your kit.
Where to find product info
Model numbers can typically be found on the product packaging or the accompanying documentation.
What timeline to expect
Expect a response from Medline within a few weeks regarding refund or replacement options.
If the manufacturer is unresponsive
- Document all attempts to contact Medline.
- Reach out to your healthcare provider for assistance.
- Consider filing a complaint with the FDA if no response is received.
How to prevent similar issues
- Ensure that surgical kits are sourced from reputable manufacturers.
- Check for recent recalls or safety notices before purchasing medical devices.
- Look for certifications showing compliance with sterilization standards.
Documentation advice
Keep records of your purchase, including receipts and any correspondence regarding the recall.
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Product Details
The recall affects multiple models of Medline surgical kits, including ROBOTIC GYN CDS-1 (Model CDS982893I) and GYN LAPAROSCOPY CDS (Model CDS983300J). These kits were widely distributed in the U.S. and internationally.
Key Facts
- Recall date: January 7, 2026
- Quantity recalled: 12,418 units
- Class II recall due to high hazard level
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Safety Guide
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