Aesculap Implant Systems LLC Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
Brand
Aesculap Implant Systems LLC
Lot Codes / Batch Numbers
UDI-DI (GTIN): 04038653067862, lots 551953371, 52024524, 52097698, 52172460, 52249972, and 52340448.
Products Sold
UDI-DI (GTIN): 04038653067862, lots 551953371, 52024524, 52097698, 52172460, 52249972, and 52340448.
Aesculap Implant Systems LLC is recalling Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per due to Packaging seal integrity not validated resulting in a lack of sterility assurance.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Packaging seal integrity not validated resulting in a lack of sterility assurance.
Recommended Action
Per FDA guidance
Recall notice issued October 1, 2019 via letter mailed USPS certified mail with return receipt. Customers are to review inventory, return affected product and the acknowledgement form. For questions contact (800) 282-9000 or email: emailorders@aesculapusa.com
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 noticePage updated: Jan 10, 2026