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SJM recallZ-0532-2026 · Glycar SA Pty., Ltd. · initiated Oct 9, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Glycar SA Pty., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The impacted lot may not meet the required tensile strength specification.

FDA root cause category: Process control

What the company is doing

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 Clearly label the identified stock as "WITHDRAWN PRODUCT" DO NOT DISTRIBUTE OR USE. 3.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]

Recall details

Recall number
Z-0532-2026
Status
Open, Classified
Initiated by the company
Oct 9, 2025
Posted by the FDA
Nov 25, 2025
Recalling firm
Glycar SA Pty., Ltd.
Quantity
18 units
Product code
DXZ
FDA submissions
K963967
Distribution
US

Product description

SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Code information (models, lots, serial numbers)

UDI/DI 05414734007269, Lot Number T2506245, exp. 2028.05.25

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

2 devices cleared under K963967 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97877).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page