Quick Facts at a Glance
- Recall Date
- December 17, 2025
- Hazard Level
- HIGH
- Brand
- Aju Pharm Co.
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Suture Anchor
- Model numbers
- Model No. 10S30002, All UDI Codes, All Lots.
- Sold at
- Unknown
- 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 Push-In Suture Anchor is a medical device used in surgical procedures to secure soft tissue to bone. These devices are critical for ensuring proper healing in various orthopedic and surgical applications.
Why This Is Dangerous
The reported failures of the Genesis Push-In Suture Anchor can lead to complications such as inadequate tissue attachment or additional surgery, posing risks to patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients using this device may face serious risks if the device fails. Immediate cessation of use is necessary to prevent potential complications.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the packaging or device itself.
- Check if the model number is 10S30002 or any UDI codes listed in the recall.
- Verify if the device was distributed in California or Puerto Rico.
Where to find product info
The model number is typically printed on the device packaging or the device itself. Check for any UDI codes as well.
What timeline to expect
Expect the refund or replacement process to take approximately 4-6 weeks.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Reach out again or ask your healthcare provider to assist.
How to prevent similar issues
- Always verify the safety record of medical devices before use.
- Consult healthcare professionals regarding any recalls affecting devices you use.
- Look for devices with strong safety certifications.
Documentation advice
Keep records of your purchase, any communications regarding the recall, and photos of the product if necessary.
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Product Details
The Genesis Push-In Suture Anchor has model number 10S30002 and is distributed nationwide in California and Puerto Rico. The recall affects 200 units.
Key Facts
- Device failures reported
- Anchor breakage and suture breakage
- Immediate use cessation advised
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Safety Guide
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