Quick Facts at a Glance
- Recall Date
- January 15, 2026
- Hazard Level
- HIGH
- Brand
- Encore Medical, LP
- 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
- Encore Medical, LP
- Product type
- Humeral Socket Insert
- Model numbers
- Lot Code: Lot: 385P1263 GTIN: 00888912144575
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 15, 2026
Reported by FDA DEVICE
March 4, 2026
RecallRadar source check
April 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Knee and Humeral socket implants contain incorrect labeling.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Encore Medical, LP or your healthcare provider for instructions. Notification method: Letter
About This Product
The RSP Humeral Socket Insert is a medical device used in shoulder prosthesis surgeries. It serves to provide stability and support in the shoulder joint for patients undergoing surgical procedures.
Why This Is Dangerous
The incorrect labeling on the device may lead to confusion in usage, potentially resulting in improper implant procedures and patient safety risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may cause inconvenience to patients and healthcare providers needing to replace or ensure the correct use of the implants.
Practical Guidance
How to identify if yours is affected
- Check the model number for 509-00-432.
- Look for the lot code: 385P1263 on the product packaging.
- Verify the product against the recall notice.
Where to find product info
Serial numbers and lot codes can typically be found on the product packaging or the device itself.
What timeline to expect
Expect a refund or replacement processing time of approximately 4-6 weeks.
If the manufacturer is unresponsive
- Document all communication attempts with Encore Medical.
- Consider contacting the FDA for further guidance.
- Keep records of your product details and any correspondence.
How to prevent similar issues
- Always verify product labels before usage.
- Consult with healthcare providers regarding product recalls.
- Stay informed about medical device safety updates.
Documentation advice
Keep a record of your purchase receipt, any correspondence with the manufacturer, and photos of the product.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recalled product is the RSP Humeral Socket Insert, 32MM +4MM, Standard HXe-plus, with model number 509-00-432. It was distributed nationwide, particularly in states including Virginia, Tennessee, and Illinois. The product is classified as Class II.
Key Facts
- Incorrect labeling identified
- Class II medical device
- Contact Encore Medical for instructions
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.