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) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 24CBQ563, 2) CDS984086I, Lot Number: 24ABO363, 3) CDS984086I, Lot Number: 23IBV204 +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
Medline Convenience Kits include a range of surgical instruments and supplies used in various medical procedures, particularly gynecological surgeries. These kits are essential for healthcare providers to ensure safe and sterile environments during operations.
Why This Is Dangerous
Calibration issues with the sterilization equipment may compromise the sterility assurance level of the kits, increasing the risk of infection during surgical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The potential for compromised sterility could lead to serious health risks for patients undergoing surgical procedures, necessitating immediate action from healthcare providers.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the packaging of the surgical kit.
- Check the list of recalled models provided by Medline.
- Contact Medline if you are unsure about your kit's status.
Where to find product info
Model numbers are typically located on the outer packaging or the instruction manual included with the kit.
What timeline to expect
Expect a refund or replacement processing time of approximately 4-6 weeks.
If the manufacturer is unresponsive
- Document all communication attempts with Medline.
- Consider filing a complaint with the FDA if there is a lack of response.
How to prevent similar issues
- Always verify the sterility of surgical kits before use.
- Check for recalls and safety alerts from manufacturers regularly.
- Purchase surgical supplies from reputable suppliers.
Documentation advice
Keep records of your purchase, communication with Medline, and any correspondence regarding the recall.
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Product Details
The recall affects various Medline surgical kits including HYSTEROSCOPY, KIT GYN ONCOLOGY LAP, and several VAGINAL HYSTERECTOMY PACK models. The model numbers include CDS984086I, DYKMBNDL91A, DYNJ0373807J, and others. The kits were distributed worldwide, including the US, and all were sold before January 2026.
Key Facts
- Recalled models include HYSTEROSCOPY and various vaginal hysterectomy packs
- Total quantity recalled: 4,415 units
- Recall initiated on January 7, 2026
- Potential for compromised sterility assurance level (SAL)
- Patients must cease use of affected products 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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