CLASS II Device recall · Reported 16 Oct 2019 · FDA Enforcement Report
CanGaroo Envelopes labeled as the following recalled by Aziyo Biologics
Aziyo Biologics is recalling CanGaroo Envelopes labeled as the following: CanGaroo Envelope (Large) (single pack), distributed nationwide in the US. The recall was initiated on 21 Aug 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0040-2020
- FDA event ID
- 83652
- Recalling firm
- Aziyo Biologics, Roswell, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Aug 2019
- FDA classified
- 4 Oct 2019
- Reported
- 16 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Pacemakers & Defibrillators
Timeline
| 21 Aug 2019 | Recall initiated by company | |
| 4 Oct 2019 | Classified by FDA | +44 days |
| 16 Oct 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution including the states of AL, AR, AZ, CA, FL, GA, HI, IL, IN, KS, KY, LA, LA, MI, MN, MO, MS, NC, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI.
Nationwide AlabamaArkansasArizonaCaliforniaFloridaGeorgiaHawaiiIllinoisIndianaKansasKentuckyLouisianaMichiganMinnesotaMissouriMississippiNorth CarolinaNew MexicoNevadaNew York
Questions about this recall
Is CanGaroo Envelopes labeled as the following: CanGaroo Envelope (Large) (single pack) recalled?
Yes. Aziyo Biologics recalled CanGaroo Envelopes labeled as the following: CanGaroo Envelope (Large) (single pack) on 21 Aug 2019. The recall is Class II and its status is Terminated. Recall number Z-0040-2020.
Why was it recalled?
Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
Which lots are affected?
1. Catalog Number CMCV-009-LRG (UDI Number 000859389005065) Lot Numbers: M18B1053, M18D1080, M18D1081, M18D1091, M18D1095, M19B1077, M19C1083, M19D1144, M19D1148; 2. Catalog Number CMCV-009-MED (UDI Number 000859389005034) Lot Numbers: M18C1071, M18D1088; 3. Catalog Number CMCV-009-XLG (UDI Number 000859389005072) Lot Numbers: M18B1051, M18B1052, M18B1054, M18C1068, M18C1069, M19D1160, M19D1163; 4. Catalog Number CMCV-009-XXL (UDI Number 000859389005119) Lot Numbers: M18D1094, M19C1101, M19C1123; 5. Catalog Number CMCV-010-LRG (UDI Number 010859389005062) Lot Numbers: M18A1007, M18M1303, M18N1330, M19B1071, M19C1104, M19C1119; 6. Catalog Number CMCV-010-MED (UDI Number 010859389005031) Lot Number M18A1015; 7. Catalog Number CMCV-010-XLG (UDI Number 010859389005079) Lot Numbers: M18F1160, M18F1161; 8. Catalog Number CMCV-010-XXL (UDI Number 010859389005116) Lot Number M18F1159
Where was it sold?
US Nationwide distribution including the states of AL, AR, AZ, CA, FL, GA, HI, IL, IN, KS, KY, LA, LA, MI, MN, MO, MS, NC, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Aziyo Biologics
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|---|---|---|---|---|---|
| Device | CLASS II | BioEnvelope, surgical mesh envelope recalled by Aziyo Biologics | Aziyo Biologics | Device Malfunction | Nationwide |
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