Quick Facts at a Glance
- Recall Date
- January 15, 2026
- Hazard Level
- HIGH
- Brand
- Encore Medical, 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
- Encore Medical, LP
- Product type
- Shoulder Prosthesis
- Model numbers
- Lot Code: Lot: 378P1382 GTIN: 00888912144544
- Sold at
- Multiple Retailers
- 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 Standard Humeral Socket Insert is part of a reverse shoulder prosthesis system used in orthopedic surgeries. Surgeons use this device to help restore mobility in patients with shoulder issues.
Why This Is Dangerous
The incorrect labeling may lead to improper use during surgery, potentially resulting in complications for patients. Proper identification and usage are critical for patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients may face delays in treatment and increased risk if they have used the recalled implant. The urgency to address the recall is high due to potential complications.
Practical Guidance
How to identify if yours is affected
- Check the product packaging for the model number 509-00-036 and lot code 378P1382.
- Confirm if the shoulder prosthesis matches the recalled description.
- Consult your healthcare provider if you are uncertain about your implant.
Where to find product info
Look for the model number and lot code on the product packaging or accompanying documentation.
What timeline to expect
Expect a processing timeline of 4-6 weeks for refunds or other actions.
If the manufacturer is unresponsive
- Follow up with Encore Medical via phone or email if you receive no response within a week.
- Document all communication attempts in case further escalation is necessary.
How to prevent similar issues
- Ensure that any medical device purchased has clear labeling and certification.
- Consult with healthcare professionals about the safety and recall history of medical devices before use.
- Stay informed about recalls in the medical device industry.
Documentation advice
Keep copies of any correspondence related to the recall, including emails and letters from the manufacturer.
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Product Details
The recall affects the RSP Standard Humeral Socket Insert, 36MM, model number 509-00-036. The affected lot code is 378P1382. The implants were sold nationwide in states including Virginia, Tennessee, Illinois, Indiana, Michigan, Colorado, Wyoming, Montana, Rhode Island, Massachusetts, New Jersey, Pennsylvania, Missouri, Oklahoma, Louisiana, Florida, and California.
Key Facts
- Recall date: January 15, 2026
- 20 shoulder prosthesis implants affected
- High hazard risk due to incorrect labeling
- Distributed nationwide in multiple states
- Contact Encore Medical for further instructions
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Safety Guide
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