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) CDS983069G, UDI-DI: 10193489923926(each), 40193489923927(case), Lot Number: 21IBD399, 2) CDS983069G, Lot Number: 21HBO921, 3) CDS983069I, UDI-DI: 10195327071868(each) +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's surgical kits are utilized in various medical procedures, providing essential instruments and materials for healthcare professionals. These kits are critical in ensuring the safety and effectiveness of surgical operations.
Why This Is Dangerous
Calibration issues in sterilization equipment can lead to insufficient sterilization of the kits, increasing the risk of infection in patients. This is particularly concerning in surgical settings where sterility is paramount.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers should act quickly to return these products to avoid potential health risks associated with compromised sterility.
Practical Guidance
How to identify if yours is affected
- Check model numbers against the recalled list provided by Medline.
- Look for lot numbers on the packaging to verify if your kit is affected.
- Contact your healthcare provider if you're unsure about your product.
Where to find product info
Model and lot numbers can typically be found on the product packaging or label attached to the kit.
What timeline to expect
Expect processing times for refunds or replacements to take 4-6 weeks after returning the recalled products.
If the manufacturer is unresponsive
- Document all communications with Medline regarding the recall.
- Follow up with a call if you do not receive a response within two weeks.
- Consider filing a complaint with the FDA if the company is unresponsive.
How to prevent similar issues
- Always check for product recalls before purchasing surgical supplies.
- Look for certifications indicating successful sterilization processes.
- Ask healthcare providers about the latest recalls related to surgical kits.
Documentation advice
Keep records of your purchase, return communications, and any correspondence with Medline regarding the recall.
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Product Details
The recall includes various surgical kits such as CHP Cochlear Supplement CDS (Models CDS983069G, CDS983069I) and ENT Head and Neck Kits (Models DYKMBNDL156, DYNJ41169). These kits were distributed worldwide, including the U.S., from various healthcare facilities.
Key Facts
- Recall date: January 7, 2026
- Report date: February 25, 2026
- Quantity recalled: 9,051 units
- Risk level: High
- Affected models: 70 different model numbers
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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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