Elite Medical Group MSI-EpiDermGlu (Iso-Butyl 2 Cyanoacrylate) tissue adhesive for soft tissue approximation; 0.22 cc plastic squeeze tubes packaged in a Tyvek/PPE pouch with paper label, 10 units per case; Manufactured by Medisav Services Inc. (MSI), 56 Elson Street, Markham, Ontario L3S 1Y7 Canada Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MSI-EpiDermGlu (Iso-Butyl 2 Cyanoacrylate) tissue adhesive for soft tissue approximation; 0.22 cc plastic squeeze tubes packaged in a Tyvek/PPE pouch with paper label, 10 units per case; Manufactured by Medisav Services Inc. (MSI), 56 Elson Street, Markham, Ontario L3S 1Y7 Canada
Brand
Elite Medical Group
Lot Codes / Batch Numbers
Product #51002, all lots
Products Sold
Product #51002, all lots
Elite Medical Group is recalling MSI-EpiDermGlu (Iso-Butyl 2 Cyanoacrylate) tissue adhesive for soft tissue approximation; 0.22 cc pl due to The liquid tissue adhesive was marketed without FDA pre-market clearance.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The liquid tissue adhesive was marketed without FDA pre-market clearance.
Recommended Action
Per FDA guidance
Recalled by letter dated 7/2/03, informing the accounts that the skin adhesive had not been approved for marketing in the United States and that they should return the product to Elite Medical.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, KS, KY, MD, MO, TN
Page updated: Jan 10, 2026