BioEnvelope — Class II medical device recall Z-0039-2020
Terminated recall by AZIYO BIOLOGICS, reported 2019-10-16, distributed nationwide. Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
| Recall number | Z-0039-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AZIYO BIOLOGICS, Roswell, GA, United States |
| Recall initiated | 2019-08-21 |
| Classified | 2019-10-04 |
| Reported by FDA | 2019-10-16 |
| Terminated | 2020-09-17 |
| Distributed | Nationwide (US) |
| Quantity | 1,018 units |
| Reason classes | device malfunction |
| Lot numbers | M18A1007, M18A1008, M18A1010, M18A1014, M18A1015, M18A1021, M18A1022, M18B1051, M18B1054, M18C1070, M18C1071, M18D1080, M18F1146, M18G1181, M18G1185, M18G1188, M18G1189 |
| Model numbers | 440576, 440577, 440578, 440579, 440622, 440623, 440625, 440626 |
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 (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.
Reason for recall
Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0039-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.