The Recall Desk

Manufacturer

Glycar SA Pty., Ltd.

2 recalls in our database name Glycar SA Pty., Ltd. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
2
Severe
0
Most recent
2025-12-03

Of the 2 recalls from Glycar SA Pty., Ltd. we have scored against our rubric, 2 (100%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • CriticalFDA (Devices)·Z-0532-2026·2025-12-03

    Smaller pericardial patches recalled over a tensile strength specification failure

    Glycar SA is recalling 18 SJM Pericardial Patches, 5 x 10 cm, because the impacted lot may not meet the required tensile strength specification. The FDA classified it Class I.

    Product
    SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0531-2026·2025-12-03

    Pericardial patches recalled because a lot may not meet tensile strength

    Glycar SA is recalling 30 SJM Pericardial Patches with EnCap Technology because the impacted lot may not meet the required tensile strength specification. The FDA classified it Class I.

    Product
    SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
    Category
    Medical Device
    Distribution
    0 states