RecallRadar

FDA Device recall Z-2623-2017

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

On 2017-07-05 the FDA classified a Class II recall of BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J by Cryolife, citing the courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2623-2017
ClassificationClass II
Statusterminated
Initiated2017-05-19
Published2017-07-05
Last updated2026-09-13 11:54 UTC
CompanyCryolife
Distributionn/a

Product

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

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2623-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.