Quick Facts at a Glance
- Recall Date
- December 17, 2025
- Hazard Level
- HIGH
- Brand
- Aju Pharm Co.
- 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
- Aju Pharm Co.
- Product type
- Surgical Anchor
- Model numbers
- Model No. 10KPN4751, 10KPN5501, All UDI Codes, All Lots.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 17, 2025
Reported by FDA DEVICE
February 4, 2026
RecallRadar source check
February 11, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Aju Pharm Co., Ltd. or your healthcare provider for instructions. Notification method: Letter
About This Product
The Genesis Knotless Anchor is a medical device used for anchoring sutures in surgical procedures. Surgeons prefer it for its ease of use and effectiveness in securing tissues during operations.
Why This Is Dangerous
Device failures lead to potential surgical complications, including insufficient tissue anchoring and increased risk during procedures. These issues can cause significant consequences for patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers must stop using the device immediately, leading to potential delays in surgical procedures. The urgency of addressing the recall is high due to the risk of device failure.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device packaging or patient records.
- Verify if your device is included in the recall list: Model No. 10KPN4751 or 10KPN5501.
- Consult your healthcare provider for verification.
Where to find product info
Model numbers and UDI codes can typically be found on the product packaging or accompanying documentation.
What timeline to expect
Expect a refund or replacement process to take approximately 4 to 6 weeks after submission of your request.
If the manufacturer is unresponsive
- Keep records of all communication attempts with the company.
- Reach out to your healthcare provider for assistance if needed.
- Consider filing a complaint with the FDA if the company is unresponsive.
How to prevent similar issues
- Thoroughly research medical devices before use, focusing on safety records and recalls.
- Always consult with healthcare providers regarding the best alternatives for surgical procedures.
- Look for devices with recent safety certifications.
Documentation advice
Document all communications regarding the recall, including emails, letters, and any calls made. Keep receipts and product packaging as evidence.
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Product Details
The Genesis Knotless Anchor is a medical device used in surgical procedures. The recalled models include Model No. 10KPN4751 and 10KPN5501, along with all UDI Codes and Lots. The product was distributed nationwide in the U.S., specifically in California and Puerto Rico.
Key Facts
- Recall date: December 17, 2025
- Model numbers: 10KPN4751, 10KPN5501
- Quantity recalled: 1,163 units
- Distribution: California and Puerto Rico
- Manufacturer: Aju Pharm Co., Ltd.
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Safety Guide
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