CLASS II Device recall · Reported 22 Dec 2021 · FDA Enforcement Report
BioGlue Surgical Adhesive recalled by CryoLife
CryoLife is recalling BioGlue Surgical Adhesive. The recall was initiated on 7 Oct 2021 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-0384-2022
- FDA event ID
- 88929
- Recalling firm
- CryoLife, Kennesaw, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Oct 2021
- FDA classified
- 15 Dec 2021
- Reported
- 22 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Hidden Drug Ingredients
- Device type
- Surgical Instruments
Timeline
| 7 Oct 2021 | Recall initiated by company | |
| 15 Dec 2021 | Classified by FDA | +69 days |
| 22 Dec 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product is not approved for use in the EU and should not have been distributed in the EU.
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
BioGlue Surgical Adhesive, Model BG3510-5-G
Where it was distributed
Distribution in the European Union only (Germany/Switzerland)
Questions about this recall
Why was it recalled?
Product is not approved for use in the EU and should not have been distributed in the EU.
Which lots are affected?
Model BG3510-5-G, Lot BG000255
Where was it sold?
Distribution in the European Union only (Germany/Switzerland)
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 26 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 CryoLife
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|---|---|---|---|---|---|
| Device | CLASS II | CryoPatch SG Pulmonary Human Cardiac Patch recalled by CryoLife | CryoLife | Device Malfunction | Nationwide |
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| Device | CLASS II | CryoPatch SG Pulmonary Hemi-Artery Patch recalled by CryoLife | CryoLife | Other | TX |
| Device | CLASS II | On-X Aortic Heart Valve with Anatomic Sewing Ring recalled by CryoLife | CryoLife | Labeling Errors | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Adaptable Beach Chair Beach Chair surgical patient positioner recalled | Quantum OPS | Device Malfunction | Nationwide |
| Device | CLASS II | Laparoscopic Prostatectomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Halyard Laparoscopy Comprehensive Pack II recalled | GRI Medical & Electronic Technology | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |