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
- Medical Convenience Kit
- Model numbers
- 1) DM1035, UDI-DI: 10193489442755(each), 40193489442756(case), Lot Number: 21BBN221, 2) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 22GBN333 +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
April 13, 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 designed for medical procedures, providing necessary instruments and supplies. These kits are utilized by healthcare providers to ensure sterile conditions during surgeries and treatments.
Why This Is Dangerous
Calibration issues with the sterilization equipment can lead to inadequate sterilization levels. This compromises the safety and efficacy of the medical devices included in the kits.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients using these kits may face health risks if the devices are not adequately sterilized. The urgency to halt use reflects the potential danger in medical settings.
Practical Guidance
How to identify if yours is affected
- Check the model number on your convenience kit.
- Verify the lot number against the recalled lots listed in the recall announcement.
- If you have a UDI-DI code, compare it with the listed UDI-DIs in the recall.
Where to find product info
Model numbers and lot numbers are typically printed on the product packaging or the devices themselves.
What timeline to expect
Expect a refund processing timeline of approximately 4-6 weeks after following the recall instructions.
If the manufacturer is unresponsive
- Document your communications with Medline.
- Contact your healthcare provider for assistance.
- Consider filing a complaint with the FDA if there is no response.
How to prevent similar issues
- Ensure future purchases have clear sterilization certifications.
- Inquire about product testing and validation processes.
- Check for recalls before using any medical devices.
Documentation advice
Keep all receipts, correspondence with Medline, and photographs of the product as evidence for your records.
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Product Details
The recall includes the LVAD Driveline Tray, Model Number: DM1035, and the KIT Surg Onc Insert Cent. Venou, Model Number: DYKMBNDL43. The products were distributed worldwide, including nationwide in the US.
Key Facts
- Recalled models: DM1035, DYKMBNDL43
- Total units recalled: 684
- Recall date: January 7, 2026
- Classification: Class II
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Safety Guide
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