CLASS I ONGOING Device recall · Reported 3 Dec 2025 · FDA Enforcement Report

SJM Pericardial Patch, with EnCap Technology cm recalled

Glycar SA Pty 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

Lot, batch or date codesUDI/DI 05414734007269, Lot Number T2506245, exp. 2028.05.25

Quantity recalled18 units

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 Pty, 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: E-Mail
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

Questions about this recall

Is SJM Pericardial Patch, with EnCap Technology cm recalled?

Yes. Glycar SA Pty recalled SJM Pericardial Patch, with EnCap Technology cm on 9 Oct 2025. The recall is Class I and its status is Ongoing. Recall number Z-0532-2026.

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?

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Glycar SA Pty

All 2

Reported	Class	Recall	Company	Reason	Where
3 Dec 2025Device	CLASS I	SJM Pericardial Patch, with EnCap Technology 9x14cm recalled	Glycar SA Pty	Device Malfunction	N/A

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