Z-0531-2026Class I

SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC...

Name: Z-0531-2026 SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC...
Creator: Glycar SA Pty., Ltd.
Published: 2025-10-09
License: https://open.fda.gov/license/

Glycar SA Pty., Ltd. / initiated 2025-10-09 / Open, Classified / root cause: manufacturing process

FDA source

Glycar SA Pty., Ltd. began a recall of SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE on 2025-10-09. FDA classified it as Class I and gives the reason as "The impacted lot may not meet the required tensile strength specification". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0531-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-10-09
Posted: 2025-11-25
Recalling firm: Glycar SA Pty., Ltd.
Product: SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Product code: DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Reason for recall: The impacted lot may not meet the required tensile strength specification.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Glycar issued a Stock Withdrawal Notification to its sole distributor on 10/09/2025. The notice explained the issue and requested the following: "Required Actions 1. Immediately identify and segregate all affected stock in your possession. 2. Clearly label the identified stock as "WITHDRAWN PRODUCT" DO NOT DISTRIBUTE OR USE. 3. Suspend any further distribution or transfer of the affected lots. 4. Provide written confirmation of the quantity and storage location of all affected stock within five (5) business days of receipt of this notification. 5. Our Quality team will coordinate collection, return, or replacement of affected product as appropriate." For questions or require further clarification, contact: Malcolm Applewhite, [email protected] On 10/17/2025, the firm issued an URGENT: MEDICAL DEVICE RECALL notice the medical facility via email. This notice explained the issue, potential risk to health, and requested the following: "Actions to be Taken by the Customer / User: 1. Identify and quarantine any affected products with lot number T2502257 in your possession. 2. Cease use of the affected device immediately. 3. Share this notice with applicable personnel within your institution. 4. Abbott will coordinate and arrange for return and replacement of affected units. 5. Complete and return the attached Acknowledgment Form within 5 business days to confirm receipt of this notice." For questions or assistance, contact: Regulatory Affairs Manager, Glycar SA (Pty) Ltd, Malcolm Applewhite, [email protected]
Quantity in commerce: 30 units
Distribution: US
Product codes and lots: UDI/DI 05414734007276, Lot Numbers: T2502257, exp. 20280128; T2505144, exp. 2028.04.11

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0531-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0531-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-25
Z-0532-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-25

Product code DXZ

K963967Class IIGlycar Pericardial PatchGlycar, Inc. / cleared 1997-10-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)