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) DYKE1455B, UDI-DI: 10193489760781(each), 40193489760782(case), Lot Number: 22IBV801, 2) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23KMC417 +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 convenience kits are designed for use in medical procedures, providing essential tools and sterile equipment for healthcare professionals. They are often used in endoscopic procedures and other medical applications where sterility is crucial.
Why This Is Dangerous
Calibration issues with the sterilization equipment may affect the sterility of the kits. This defect raises serious concerns about the safety of patients who rely on these medical devices for treatment.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers and patients relying on these kits for safe medical procedures. Compromised sterility may pose immediate health risks, necessitating urgent action from those who possess these products.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the product packaging or label.
- Check the lot number against the list of affected lots provided in the recall notice.
- Contact Medline Industries for confirmation if unsure.
Where to find product info
Model numbers and lot numbers can typically be found on the product packaging or in the accompanying documentation.
What timeline to expect
Expect a processing time of 4-6 weeks for refunds or replacements after returning the product.
If the manufacturer is unresponsive
- Document all communication with Medline Industries.
- Reach out again via different communication methods, such as phone or email.
- Consider filing a complaint with consumer protection agencies if unresponsive.
How to prevent similar issues
- Always check for recall notices before using medical devices.
- Ensure the products are from reputable manufacturers with good safety records.
- Look for certification marks indicating compliance with safety standards.
Documentation advice
Keep copies of receipts, correspondence with the company, and any documentation related to the recall for your records.
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Product Details
The recall involves the BAPTIST FLOYD ENDO GI KIT (Model Number: DYKE1455B) and GI LAB OTHER ENDO KIT (Model Number: DYKE1721). These products were distributed worldwide, including throughout the U.S. The affected kits were manufactured in various lots.
Key Facts
- Recall date: January 7, 2026
- Total units recalled: 23,238
- Risk level: High
- Affected models: DYKE1455B, DYKE1721
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Safety Guide
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