CanGaroo Envelopes labeled as the following: 1 — Class II medical device recall Z-0040-2020
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-0040-2020 |
|---|---|
| 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 | 2,693 units |
| Reason classes | device malfunction |
| Lot numbers | M18A1007, M18A1015, M18B1051, M18B1052, M18B1053, M18B1054, M18C1068, M18C1069, M18C1071, M18D1080, M18D1081, M18D1088, M18D1091, M18D1094, M18D1095, M18F1159, M18F1160, M18F1161, M18M1303, M18N1330, M19B1071, M19B1077, M19C1083, M19C1101, M19C1104, M19C1119, M19C1123, M19D1144, M19D1148, M19D1160, M19D1163 |
| Model numbers | CMCV-009-LRG, CMCV-009-MED, CMCV-009-XLG, CMCV-009-XXL, CMCV-010-LRG, CMCV-010-MED, CMCV-010-XLG, CMCV-010-XXL |
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 Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator 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. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
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-0040-2020. 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.