CryoLife, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2556-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class II

Date Initiated: June 4, 2018

Date Posted: August 1, 2018

Recall Number: Z-2556-2018

Event ID: 80276

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.

Status: Terminated

Product Quantity: 855 Total

Code Information:

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

Distribution Pattern:

Distribution is to Japan

Voluntary or Mandated:

Voluntary: Firm initiated