CLASS II Device recall · Reported 5 Jul 2017 · FDA Enforcement Report

BioGlue Surgical Adhesive recalled by CryoLife

CryoLife is recalling BioGlue Surgical Adhesive. The recall was initiated on 19 May 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code 17MJX002, Model/Catalog Number BG3510-5-J

Quantity recalled705 single pack boxes

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-2623-2017
FDA event ID: 77369
Recalling firm: CryoLife, Kennesaw, GA
Classification: Class II
Status: Terminated
Recall initiated: 19 May 2017
FDA classified: 23 Jun 2017
Reported: 5 Jul 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Surgical Instruments

Timeline

19 May 2017	Recall initiated by company
23 Jun 2017	Classified by FDA	+35 days
5 Jul 2017	Published in enforcement report	+12 days

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

Reason for recall

The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.

Product as listed by the FDA

BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J

Where it was distributed

Product distributed in Japan.

Questions about this recall

Is BioGlue Surgical Adhesive recalled?

Yes. CryoLife recalled BioGlue Surgical Adhesive on 19 May 2017. The recall is Class II and its status is Terminated. Recall number Z-2623-2017.

Why was it recalled?

The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.

Which lots are affected?

Lot Code 17MJX002, Model/Catalog Number BG3510-5-J

Where was it sold?

Product distributed in 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 21 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	Sterility	Nationwide
30 Dec 2020Device	CLASS II	CryoValve SG Pulmonary Human Heart Valve recalled by CryoLife	CryoLife	Sterility	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 Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide