Class I U.S. Food and Drug Administration

Glycar SA Pty., Ltd. SJM Pericardial Patch, with EnCap Technology 9x14cm recall: The impacted lot may not meet the required tensile strength specification

Recall published 11 months ago

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

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: The impacted lot may not meet the required tensile strength specification.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0531-2026
Published
December 3, 2025
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Glycar SA Pty., Ltd.
Product type
Medical devices
Units affected
30 units
Made in
South Africa
Lot / code info
UDI/DI 05414734007276, Lot Numbers: T2502257, exp. 20280128; T2505144, exp. 2028.04.11
UPC codes
05414734007276

Products covered by this recall

SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Check your product

The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 05414734007276

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • T2502257
  • exp. 20280128

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 20280128
  • 2028.04.11 — 30 units

Model or item number

On the rating label, the box or the instruction sheet.

  • REF C0914

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Glycar SA Pty., Ltd. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Glycar SA Pty., Ltd. — 1 Albert Road, Irene

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Glycar SA Pty., Ltd. medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 05414734007276; lot code T2502257, exp. 20280128; best-by date 20280128 or 2028.04.11 — 30 units; model number REF C0914. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

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