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) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 22GBP895, 2) DYKMBNDL104, Lot Number: 21IBV636, 3) DYKMBNDL104, Lot Number: 21FBP706 +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 pre-packaged surgical kits designed for various medical procedures, including ophthalmology and breast surgeries. They are used in healthcare settings for efficiency and sterility during operations.
Why This Is Dangerous
Calibration issues in the sterilization equipment could lead to compromised sterility, increasing the risk of infections in patients. Proper sterilization is critical to ensure patient safety during surgical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall necessitates immediate action by healthcare providers, potentially disrupting scheduled procedures and requiring the use of alternative sterile kits.
Practical Guidance
How to identify if yours is affected
- Check the model number on the packaging or product
- Verify if the model number matches any of the recalled kits
- Look for the lot number on the kit to confirm recall status
Where to find product info
Model numbers and lot numbers can typically be found on the packaging or label affixed to the kit.
What timeline to expect
Expect processing for refunds or replacements to take approximately 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Document your attempts to contact Medline
- Follow up with a second inquiry if no response is received within two weeks
- Consider contacting relevant health authorities if issues persist
How to prevent similar issues
- Always verify the sterilization certification of medical devices
- Choose products from reputable manufacturers with a good safety record
- Stay informed about recalls in the medical device sector
Documentation advice
Keep records of all communications with Medline, including emails and phone call notes, along with any receipts or shipping confirmations related to the return.
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Product Details
The recall involves 35 different surgical kits, including models DYKMBNDL104 and DYNJ17219C. These products were distributed worldwide, including across the U.S.
Key Facts
- Recall date: January 7, 2026
- Report date: February 25, 2026
- Total units recalled: 4,853
- Class II recall due to potential health hazards
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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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