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
- Convenience Kits
- Model numbers
- 1) 00-401993O, UDI-DI: 10195327517366(each), 40195327517367(case), Lot Number: 23KBH528, 2) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 24DDA188 +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 convenience kits are medical device packages designed for various healthcare procedures, including central line insertions and other sterile applications. Healthcare providers use these kits to ensure a sterile environment during procedures.
Why This Is Dangerous
Calibration issues with the sterilization equipment may lead to inadequate sterilization of the devices, increasing the risk of potential infections if used on patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must stop using these devices immediately to avoid any risk of infection. The recall may cause inconvenience in medical settings, requiring alternative products.
Practical Guidance
How to identify if yours is affected
- Locate the model number and lot number on your convenience kit packaging.
- Compare the model numbers against the list provided in the recall notice.
- If your product matches any of the recalled model numbers, stop using it immediately.
Where to find product info
Model numbers and lot numbers can typically be found on the packaging or attached labels of the kits.
What timeline to expect
Expect refund processing to take approximately 4-6 weeks after returning the product to Medline.
If the manufacturer is unresponsive
- Document all communication attempts with Medline.
- Contact your healthcare provider for additional support in resolving the issue.
- Consider filing a complaint with the FDA if the response is inadequate.
How to prevent similar issues
- Always purchase medical devices from reputable suppliers.
- Check the FDA website regularly for safety alerts and recalls.
- Ensure that products are certified for safety and sterility before use.
Documentation advice
Keep a record of the recall notice, any correspondence with Medline, and receipts or proof of purchase for your records.
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Product Details
The recall includes 24 specific models, such as the PICC LINE TRAY (Model Number: 00-401993O) and CODE CART ADULT 4 CENTRAL LINE (Model Numbers: ACC010268B and ACC010268C). These kits were distributed worldwide, including throughout the United States.
Key Facts
- Recall date: January 7, 2026
- Reported date: February 25, 2026
- Quantity recalled: 5,346 units
- Class II recall
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Safety Guide
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