CryoLife BioGlue Spreader Tip Recall: Incorrect Packaging May Lead to Missing Components
CryoLife recalls BioGlue Spreader Tips due to missing Syringe Spreader Tip pouches in packaging. Affected units have model BG3510-5-J and lot 18MJX002. Consumers should check packaging for indicator label.
Lower-risk recall
The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied to the Syringe Applicator Tip pouches and Syringe Spreader Tip pouches were not included in the boxes.
Contact the company
What happened, in plain English
CryoLife is recalling BioGlue Spreader Tips that may not include Syringe Spreader Tip pouches. This could lead to incomplete medical procedures during surgery. The recall affects specific model and lot numbers. Read more at govinfonow.com/recall/70903-cryolife-bioglue-spreader-tip-recall-incorrect-packaging-may-lead-to.
Source Summary by GovInfoNow · govinfonow.com/recall/70903-cryolife-bioglue-spreader-tip-recall-incorrect-packaging-may-lead-to · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2556-2018
Cite this page
“CryoLife BioGlue Spreader Tip Recall: Incorrect Packaging May Lead to Missing Components.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70903-cryolife-bioglue-spreader-tip-recall-incorrect-packaging-may-lead-to. Based on FDA recall #Z-2556-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2556-2018%22&limit=1).
Why it’s dangerous
The Spreader Tip pouches were not included in the boxes, meaning the necessary components for surgical use might be missing. This could cause incomplete application of BioGlue during procedures. However, the hazard does not involve immediate injury risks.
Who’s affected
Adult patients undergoing surgery who use BioGlue for vessel repair may be affected. Medical professionals handling the specific model and lot numbers are most at risk.
How to tell if you have this one
Check for model number BG351:5-J and lot number 18MJX002 on the packaging. The indicator label should read '2 1/8" x 1 1/4"'.
- Brand
CryoLife- Category
Medical device
What to do — step by step
Check Packaging
Look for the model number BG3510-5-J and lot number 18MJX002 on the packaging.
How this recall unfolded
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2556-2018 (June 4, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2556-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.