Quick Facts at a Glance
- Recall Date
- November 11, 2025
- 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 Implant Kit
- Model numbers
- Lot 19019 UDI-DI 10193489131703
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 11, 2025
Reported by FDA DEVICE
December 17, 2025
RecallRadar source check
December 24, 2025
Consumer action
Use the official remedy and keep documentation.
Hazard Information
There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill guide may prolong the surgical procedure.
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
The DEXLOCK Achilles Repair Implant Kit is used in surgical procedures to repair Achilles tendon injuries. Healthcare providers purchase these kits for their critical role in ensuring successful surgeries.
Why This Is Dangerous
The defect occurs when the drill bit fuses to the bushing within the drill guide, which can hinder the surgical process and lead to complications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients may experience delays in surgical procedures, which can affect recovery times and overall health outcomes.
Practical Guidance
How to identify if yours is affected
- Locate the model number and lot number on the packaging or kit.
- Verify if the model number is MAKT4520 and lot number is Lot 19019 UDI-DI 10193489131703.
- Check any notification letters from Medline Industries for specific recall details.
Where to find product info
The model number and lot number are typically found on the product packaging or instruction manual.
What timeline to expect
Expect a refund or replacement processing time of approximately 4 to 6 weeks.
If the manufacturer is unresponsive
- Document all attempts to contact Medline Industries.
- Follow up with a phone call or email if no response is received within a week.
- Consider contacting consumer protection agencies for assistance.
How to prevent similar issues
- Always check for recent recalls on medical devices before use.
- Ensure that your healthcare provider is aware of any recalls related to surgical tools.
- Look for FDA approval and safety certifications when purchasing medical devices.
Documentation advice
Keep a record of your purchase receipt, any communication regarding the recall, and photographic evidence of the device.
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Product Details
The recalled product is the DEXLOCK Achilles Repair Implant Kits, model MAKT4520, with lot number Lot 19019 UDI-DI 10193489131703. These kits were distributed across various states including Alabama, Texas, and Florida, and are classified as Class II medical devices.
Key Facts
- Recall Date: November 11, 2025
- Quantity Recalled: 163 kits
- Distribution: Nationwide in 20 states
- Classification: Class II
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Safety Guide
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