FDA Medical devices recall ·
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0531-2026
- Date
- (initiated October 9, 2025)
- Company / brand
- Glycar SA Pty., Ltd.
1 Albert Road, Irene, N/A, South Africa - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 30 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Why was it recalled?
The impacted lot may not meet the required tensile strength specification.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 05414734007276, Lot Numbers: T2502257, exp. 20280128; T2505144, exp. 2028.04.11
Distribution
US
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0531-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.