CryoLife Recalls BioGlue Surgical Adhesive Due to Albumin Component Failure
CryoLife, Inc. is recalling 6,190 units of BioGlue Surgical Adhesive because the serum albumin component failed to meet internal shelf-life specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a failure to meet internal specifications, which fits the criteria for a moderate severity rating.
Plain-English summary
CryoLife, Inc. is recalling 6,190 units of BG3515-5 US 5mL BioGlue Surgical Adhesive. The product is indicated for use as an adjunct to standard methods of achieving hemostasis in adult patients undergoing open surgical repair of large vessels, such as the aorta, femoral, and carotid arteries.
The recall was initiated because the serum albumin component monomer failed to meet internally established end-of-shelf-life specifications. The affected units were distributed nationwide, including Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, and WI.
Healthcare facilities and distributors should check their inventory for the specific lot codes listed in the recall notice and stop using the affected units. Consumers who have purchased this product should contact their healthcare provider for guidance on next steps.
The recalled product
- Product
- BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of of large vessels (such as aorta, femoral, a
- Manufacturer
- CryoLife, Inc.
- Hazard
- Affected units
- 6,190
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)
- 12MUV034
- 12MUX035
- 12MUV069
- 12MUV037
- 12MUV038
- 12MUV040
- 12MUV041
- 12MUV042
- 12MUV043
- 12MUV044
- 12MUV045
- 12MUV046
- 12MUV047
- 12MUV048
- 12MUV049
- 12MUV050
- 12MUV051
- 12MUV052
- 12MUV053
- 12MUV054
Distribution
Related recalls
Same manufacturer · CryoLife, Inc.
See all →- ModerateBioGlue Surgical Adhesive recalled for unauthorized distribution in European Union
FDA (Devices) · 2021-12-22
- HighCryoLife Recalls CryoValve SG Pulmonary Heart Valves Due to Microbial Test Failures
FDA (Devices) · 2020-12-30
- SevereCryoLife Recalls CryoPatch SG Pulmonary Human Cardiac Patch Units
FDA (Devices) · 2020-12-30
- SevereCryoLife Pulmonary Hemi-Artery Patch Recalled for Donor Infection
FDA (Devices) · 2019-05-01
- LowCryoLife Recalls Two On-X Aortic Heart Valves for Mislabeled Serial Numbers
FDA (Devices) · 2019-04-03
Same hazard · specification failure
See all →- ModerateZeiss Intrabeam Spherical Applicator failed manufacturing specifications
FDA (Devices) · 2026-07-08
- HighSkin cancer aid recalled because it may not meet specifications
FDA (Devices) · 2025-12-03
- CriticalSmaller pericardial patches recalled over a tensile strength specification failure
FDA (Devices) · 2025-12-03
- CriticalPericardial patches recalled because a lot may not meet tensile strength
FDA (Devices) · 2025-12-03
- Low