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. BAB-55003ch, BAN-55003b, SAB-30002e, 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 Fixone Biocomposite Anchor is used in surgical procedures to anchor sutures securely. It is typically used in orthopedic surgeries and other medical applications requiring tissue fixation.
Why This Is Dangerous
The device failure can lead to serious complications during surgical procedures. Breakage or bending of the anchor compromises its effectiveness and can pose risks to patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may cause significant delays in surgical procedures for patients relying on the affected device. It emphasizes the importance of using safe and reliable medical devices.
Practical Guidance
How to identify if yours is affected
- Check the model number against the recalled models.
- Review UDI codes listed in the recall announcement.
- Determine if the product was purchased after the specified date.
Where to find product info
Serial numbers and UDI codes can typically be found on the product packaging or the device itself.
What timeline to expect
4-6 weeks for refund processing once the product is returned.
If the manufacturer is unresponsive
- Follow up with Aju Pharm Co. via phone or email.
- Document all correspondence regarding the recall.
- Contact the FDA if you do not receive a timely response.
How to prevent similar issues
- Look for FDA approval or clearance when purchasing medical devices.
- Ensure the manufacturer has a reliable safety record.
- Consult healthcare professionals regarding device safety.
Documentation advice
Keep records of your purchase, including receipts and correspondence with the manufacturer.
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Product Details
The recalled Fixone Biocomposite Anchors include Model No. BAB-55003ch, BAN-55003b, and SAB-30002e. The devices were distributed nationwide in California and Puerto Rico. Affected products include all UDI codes and lots.
Key Facts
- Distributed nationwide in CA and PR
- Class II recall due to device failure
- Stop using the product immediately
- Contact Aju Pharm Co. for instructions
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Safety Guide
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