Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BioEnvelope Recalled by AZIYO BIOLOGICS Due to Possible suture brittleness or breakage along the Envelope...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact AZIYO BIOLOGICS directly.
Affected Products
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 (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Quantity: 1018 units
Why Was This Recalled?
Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About AZIYO BIOLOGICS
AZIYO BIOLOGICS has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report