CLASS II Device recall · Reported 1 Aug 2018 · FDA Enforcement Report

BioGlue Spreader Tip, Sterile recalled by CryoLife

CryoLife is recalling BioGlue Spreader Tip, Sterile. The recall was initiated on 4 Jun 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number BG3510-5-J, Lot Number 18MJX002

Quantity recalled855 Total

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-2556-2018
FDA event ID: 80276
Recalling firm: CryoLife, Kennesaw, GA
Classification: Class II
Status: Terminated
Recall initiated: 4 Jun 2018
FDA classified: 26 Jul 2018
Reported: 1 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

4 Jun 2018	Recall initiated by company
26 Jul 2018	Classified by FDA	+52 days
1 Aug 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for 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.

Product as listed by the FDA

BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: 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 large vessels (such as aorta, femoral , and carotid arteries).

Where it was distributed

Distribution is to Japan

Questions about this recall

Why was it recalled?

Which lots are affected?

Model Number BG3510-5-J, Lot Number 18MJX002

Where was it sold?

Distribution is to Japan

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

All 14

Reported	Class	Recall	Company	Reason	Where
22 Dec 2021Device	CLASS II	BioGlue Surgical Adhesive recalled by CryoLife	CryoLife	Hidden Drug Ingredients	GA
30 Dec 2020Device	CLASS II	CryoPatch SG Pulmonary Human Cardiac Patch recalled by CryoLife	CryoLife	Device Malfunction	Nationwide
30 Dec 2020Device	CLASS II	CryoValve SG Pulmonary Human Heart Valve recalled by CryoLife	CryoLife	Device Malfunction	Nationwide
1 May 2019Device	CLASS II	CryoPatch SG Pulmonary Hemi-Artery Patch recalled by CryoLife	CryoLife	Other	TX
3 Apr 2019Device	CLASS II	On-X Aortic Heart Valve with Anatomic Sewing Ring recalled by CryoLife	CryoLife	Labeling Errors	Nationwide

Other Hip & Knee Implants recalls

All 3,115

Reported	Class	Recall	Company	Reason	Where
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21 Oct 2026Device	CLASS II	Grafton" DBM and Grafton Plus" DBM contain demineralized recalled	Medtronic Sofamor Danek USA	Other Bacterial Contamination	Nationwide
21 Oct 2026Device	CLASS II	Triathlon Hinge Femoral Prep Tray recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	NJ
14 Oct 2026Device	CLASS II	Intellijoint Navigation System: Workstation G2 Configured recalled	Intellijoint Surgical	Device Malfunction	Nationwide