CLASS I ONGOING Device recall · Reported 3 Dec 2025 · FDA Enforcement Report
SJM Pericardial Patch, with EnCap Technology cm recalled
Glycar SA is recalling SJM Pericardial Patch, with EnCap Technology cm. The recall was initiated on 9 Oct 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0532-2026
- FDA event ID
- 97877
- Recalling firm
- Glycar SA, Irene, N/A
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 9 Oct 2025
- FDA classified
- 25 Nov 2025
- Reported
- 3 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 9 Oct 2025 | Recall initiated by company | |
| 25 Nov 2025 | Classified by FDA | +47 days |
| 3 Dec 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The impacted lot may not meet the required tensile strength specification.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Where it was distributed
US
Questions about this recall
Why was it recalled?
The impacted lot may not meet the required tensile strength specification.
Which lots are affected?
UDI/DI 05414734007269, Lot Number T2506245, exp. 2028.05.25
Where was it sold?
US
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97877| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | SJM Pericardial Patch, with EnCap Technology 9x14cm recalled | Glycar SA | Device Malfunction | N/A |
More recalls from Glycar SA
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | SJM Pericardial Patch, with EnCap Technology 9x14cm recalled | Glycar SA | Device Malfunction | N/A |
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