Quick Facts at a Glance
- Recall Date
- October 9, 2025
- Hazard Level
- HIGH
- Brand
- Glycar SA
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Glycar SA
- Product type
- Pericardial Patch
- Model numbers
- REF C0510, UDI/DI 05414734007269, Lot Number T2506245
- Sizes
- 5x10 cm
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 9, 2025
Reported by FDA DEVICE
December 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The impacted lot may not meet the required tensile strength specification.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Glycar SA Pty., Ltd. or your healthcare provider for instructions. Notification method: E-Mail
About This Product
The SJM Pericardial Patch with EnCap Technology is used in intracardiac repair as a patch material. It is produced by Glycar SA and distributed in the United States to healthcare facilities.
Why This Is Dangerous
The recall notes the affected lot may not meet the required tensile strength specification, potentially compromising device performance.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects 18 units distributed in the US. There is a risk of device performance issues during surgical use; no injuries have been reported yet.
Practical Guidance
How to identify if yours is affected
- 1. Verify model REF C0510.
- 2. Verify lot number T2506245.
- 4. Check expiration date 2028-05-25.
- 5. If affected, stop use and contact Glycar SA Pty. Ltd. for instructions.
Where to find product info
Recall notice and FDA enforcement page at the provided link. Look for model, lot, and UDI numbers on device labeling and packaging.
What timeline to expect
Not specified in the notice.
If the manufacturer is unresponsive
- Contact Glycar SA Pty. Ltd. with the recall notice.
- If no response, consult your healthcare provider or regulatory authority.
How to prevent similar issues
- Always verify model numbers and lot numbers before implantation.
- Monitor for recall notices related to cardiac patch materials.
- Prefer suppliers with robust post-market surveillance and clear recall processes.
Documentation advice
Keep the recall notice, device labeling, sales orders, and correspondence with Glycar SA for records.
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Product Details
Model: REF C0510; Product: SJM Pericardial Patch with EnCap Technology; Size: 5x10 cm; UDI/DI: 05414734007269; Lot Number: T2506245; Expiration: 2028-05-25; Distribution: United States; Quantity: 18 units; Brand: Glycar SA
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model REF C0510
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Safety Guide
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