Medtronic Xomed, Inc. Lamicel 20PK 5MM INTL Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Lamicel 20PK 5MM INTL
Brand
Medtronic Xomed, Inc.
Lot Codes / Batch Numbers
UDI: 20885074749055, SPONGE 2203-501EX LAMICEL 20PK 5MM INTL, 2203-501EX, Lots 9642542, 9657414, 9657415, 9657416, 9677915, 9707331, 9707338, 9707334, 9712918
Products Sold
UDI: 20885074749055; SPONGE 2203-501EX LAMICEL 20PK 5MM INTL; 2203-501EX; Lots 9642542, 9657414, 9657415, 9657416, 9677915, 9707331, 9707338, 9707334, 9712918
Medtronic Xomed, Inc. is recalling Lamicel 20PK 5MM INTL due to Routine sterilization dose does not meet the required Sterility Assurance Level.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Routine sterilization dose does not meet the required Sterility Assurance Level.
Recommended Action
Per FDA guidance
Medtronic will send the Consignee Notification and Customer Confirmation Form (or equivalent record) to each listed consignee. Consignees will be asked to confirm receipt of FCA notification.
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
IN
Page updated: Jan 10, 2026