The Recall Desk

Manufacturer

AZIYO BIOLOGICS

2 recalls in our database name AZIYO BIOLOGICS as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2019-10-16

Of the 2 recalls from AZIYO BIOLOGICS we have scored against our rubric, 0 (0%) 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

  • HighFDA (Devices)·Z-0039-2020·2019-10-16

    Aziyo BioEnvelope Surgical Mesh Recalled for Possible Suture Brittleness

    Aziyo Biologics is recalling BioEnvelope surgical mesh envelopes due to possible suture brittleness or breakage along the seam before the expiration date.

    Product
    BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Larg
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0040-2020·2019-10-16

    AZIYO BIOLOGICS Recalls CanGaroo Envelopes Due to Suture Brittleness

    AZIYO BIOLOGICS is recalling CanGaroo Envelopes because sutures may become brittle or break before expiration. The devices are used to secure cardiac and neurostimulator implants.

    Product
    CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Env
    Category
    Medical Device
    Distribution
    Distributed nationwide