Aesculap Implant Systems LLC AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
Brand
Aesculap Implant Systems LLC
Lot Codes / Batch Numbers
UDI-DI (GTIN): 04046955063277
Products Sold
UDI-DI (GTIN): 04046955063277
Aesculap Implant Systems LLC is recalling AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument des due to Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
Recommended Action
Per FDA guidance
Field Action Notification letter was issued September 25, 2019 via letter sent 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 via email at: 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