The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0040-2020·Announced 2019-10-16

AZIYO BIOLOGICS Recalls CanGaroo Envelopes Due to Suture Brittleness

AZIYO BIOLOGICS is recalling CanGaroo Envelopes because sutures may become brittle or break before expiration. The devices are used to secure cardiac and neurostimulator implants.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential structural defect (suture breakage) that could compromise the stability of implanted devices, representing a risk of harm where specific injury reports are not detailed in the provided source text.

Plain-English summary

AZIYO BIOLOGICS is recalling 2,693 units of CanGaroo Envelopes. The recall covers single and multi-pack sizes including Large, Medium, Extra Large, and Extra Extra Large variants. These envelopes are intended to securely hold cardiac implantable electronic devices, such as pacemakers and defibrillators, or implantable neurostimulators, such as vagus nerve stimulators and deep brain stimulators, to create a stable environment when implanted in the body.

The recall is being conducted because of possible suture brittleness or breakage along the Envelope seam before the expiration date of the device. The affected products were distributed nationwide in the United States, including in Alabama, Arkansas, Arizona, California, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.

Healthcare providers and patients should check their inventory and patient records for the specific catalog numbers and lot numbers listed in the official recall notice. If a CanGaroo Envelope from this recall is currently implanted, patients should contact their healthcare provider for evaluation and guidance.

The recalled product

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…
Manufacturer
AZIYO BIOLOGICS
Category
Medical Device — Implantable Device Accessories
Hazard
Affected units
2,693

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • M18D1080
  • M18D1081
  • M18D1091
  • M18D1095
  • M19B1077
  • M19C1083
  • M19D1144
  • M19D1148
  • M18D1088
  • M18B1052
  • M18B1054
  • M18C1068
  • M18C1069
  • M19D1160
  • M19D1163
  • M19C1101
  • M19C1123
  • M18M1303
  • M18N1330
  • M19B1071

Distribution

Distributed nationwide across the United States.

The notice also names 30 states specifically:

Part of a larger recall action

This product is one of 2 recalled by AZIYO BIOLOGICS under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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