SJM Pericardial Patches Recalled for Potential Tensile Strength Failure

Agency Publication Date: November 25, 2025

Summary

Glycar SA Pty., Ltd. is recalling 48 units of SJM Pericardial Patches with EnCap Technology (9x14cm and 5x10cm sizes). These patches, which are implanted during cardiac and vascular surgeries, may not meet required tensile strength specifications. This defect means the patches could tear or fail to hold together as intended after being surgically placed in a patient.

Risk

If an implanted patch fails due to low tensile strength, it can lead to serious medical complications including internal bleeding, loss of structural support for heart tissues, or the need for additional emergency surgery to replace the failing patch.

What You Should Do

This recall involves SJM Pericardial Patches with EnCap Technology in sizes 9x14cm (Model REF C0914) and 5x10cm (Model REF C0510).
Affected units of the 9x14cm size include lot numbers T2502257 (Expiration 2028-01-28) and T2505144 (Expiration 2028-04-11).
Affected units of the 5x10cm size include lot number T2506245 (Expiration 2028-05-25).
Stop using the recalled devices immediately and sequester any remaining inventory from clinical use.
Contact Glycar SA Pty., Ltd. or your medical device distributor to arrange for the return, replacement, or corrective action for any unused patches.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information regarding this device recall.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: SJM Pericardial Patch, with EnCap Technology 9x14cm

Variants: 9x14cm, PETP, PTFE, Polypropylene

Model / REF:

C0914

Lot Numbers:

T2502257 (exp. 20280128)

T2505144 (exp. 2028.04.11)

UDI:

05414734007276

Recall #: Z-0531-2026; Quantity: 30 units

Product: SJM Pericardial Patch, with EnCap Technology 5x10 cm

Variants: 5x10 cm, PETP, PTFE, Polypropylene

Model / REF:

C0510

Lot Numbers:

T2506245 (exp. 2028.05.25)

UDI:

05414734007269

Recall #: Z-0532-2026; Quantity: 18 units

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97877

Status: Active

Manufacturer: Glycar SA Pty., Ltd.

Sold By: Hospitals; Surgical Centers; Medical Device Distributors

Manufactured In: South Africa

Units Affected: 2 products (30 units; 18 units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves SJM Pericardial Patches with EnCap Technology in sizes 9x14cm (Model REF C0914) and 5x10cm (Model REF C0510).

Affected units of the 9x14cm size include lot numbers T2502257 (Expiration 2028-01-28) and T2505144 (Expiration 2028-04-11).

Affected units of the 5x10cm size include lot number T2506245 (Expiration 2028-05-25).

Stop using the recalled devices immediately and sequester any remaining inventory from clinical use.

Contact Glycar SA Pty., Ltd. or your medical device distributor to arrange for the return, replacement, or corrective action for any unused patches.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information regarding this device recall.

Affected Products

Product: SJM Pericardial Patch, with EnCap Technology 9x14cm

Variants: 9x14cm, PETP, PTFE, Polypropylene

Model / REF:

C0914

Lot Numbers:

T2502257 (exp. 20280128)

T2505144 (exp. 2028.04.11)

UDI:

05414734007276

Recall #: Z-0531-2026; Quantity: 30 units

Product: SJM Pericardial Patch, with EnCap Technology 5x10 cm

Variants: 5x10 cm, PETP, PTFE, Polypropylene

Model / REF:

C0510

Lot Numbers:

T2506245 (exp. 2028.05.25)

UDI:

05414734007269

Recall #: Z-0532-2026; Quantity: 18 units