FDAAugust 21, 2019device
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-pac...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
What to do
FDA enforcement status: Terminated
Brands named
aziyo biologicsaziyo
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACanGaroo 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 Envelope (Large) (5 pack); 6. CanGaroo Envelo...2019-08-21
- FDABio-MAC Cannula (Needle) Set2015-01-23
- FDABio-CORE Cannula (Needle) Set2015-01-23
- FDABio-PLASTY Cannula (Needle)2015-01-23
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →