CLASS II Device recall · Reported 16 Oct 2019 · FDA Enforcement Report
BioEnvelope, surgical mesh envelope recalled by Aziyo Biologics
Aziyo Biologics is recalling BioEnvelope, surgical mesh envelope, 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-0039-2020
- 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
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.
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 BioEnvelope, surgical mesh envelope recalled?
Yes. Aziyo Biologics recalled BioEnvelope, surgical mesh envelope on 21 Aug 2019. The recall is Class II and its status is Terminated. Recall number Z-0039-2020.
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 440576 (UDI Number 004035479160524) Lot Numbers: M18A1010, M18A1022, M18C1070, M18G1185; 2. Catalog Number 440577 (UDI Number 004035479160531) Lot Number M18A1021; 3. Catalog Number 440578 (UDI Number 004035479160548) Lot Numbers: M18A1008, M18B1051, M18G1181; 4. Catalog Number 440579 (UDI Number 004035479160555) Lot Numbers: M18F1146, M18G1188; 5. Catalog Number 440622 (UDI Number 004035479160616) Lot Numbers: M18A1007, M18D1080; 6. Catalog Number 440623 (UDI Number 004035479160623) Lot Numbers: M18A1015, M18C1071; 7. Catalog Number 440625 (UDI Number 004035479160647) Lot Number M18G1189; 8. Catalog Number 440626 (UDI Number 004035479160654) Lot Numbers: M18A1014; M18B1054
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
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | CanGaroo Envelopes labeled as the following recalled by Aziyo Biologics | Aziyo Biologics | Device Malfunction | Nationwide |
Other Pacemakers & Defibrillators recalls
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|---|---|---|---|---|---|
| Device | CLASS II | DermaV Laser System recalled by Lutronic | Lutronic | Other | Nationwide |
| Device | CLASS II | Convenience kits containing select SKUs of Polycarbonate recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits: Loop Pack DYNJ61460C Open Heart recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Medline convenience kits: Acl Pack DYNJ64161C Arthroscopy recalled | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS II | Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled | Medline Industries | Device Malfunction | Nationwide |