Glycar SA Pty., Ltd. medical device recall: SJM Pericardial Patch
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97877
- Recall initiated
- Oct 9, 2025
- Classified by FDA
- Nov 25, 2025
- Posted in Enforcement Report
- Dec 3, 2025
- Recalling firm
- Glycar SA Pty., Ltd.
- Firm location
- Irene, South Africa
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Products in this event
- 2
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
The impacted lot may not meet the required tensile strength specification.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Oct 9, 2025. FDA classified it 47 days later, on Nov 25, 2025. This recall event covers 2 separate products, each with its own FDA recall number. Distribution reported by FDA: US
Recalled products (2)
Z-0531-2026 Class I Ongoing
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Codes / lots: UDI/DI 05414734007276, Lot Numbers: T2502257, exp. 20280128; T2505144, exp. 2028.04.11
Quantity: 30 units
Z-0532-2026 Class I Ongoing
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Codes / lots: UDI/DI 05414734007269, Lot Number T2506245, exp. 2028.05.25
Quantity: 18 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97877
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.