Aesculap Implant Systems LLC Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
Brand
Aesculap Implant Systems LLC
Lot Codes / Batch Numbers
GUIDID: 04046963469054 Lot Number: 22002834
Products Sold
GUIDID: 04046963469054 Lot Number: 22002834
Aesculap Implant Systems LLC is recalling Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Ar due to Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.
Recommended Action
Per FDA guidance
Aesculap Inc, a B. Braun company issued Urgent Medical Device Recall Notification Letter dated 5/18/23. Letter states reason for recall, health risk and action to take: Review the Device Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and all concerned persons are informed about this voluntary product recall. 2. Determine your current inventory of the affected product within your facility. (See for instructions in identifying impacted devices.) 3. Cease use and quarantine product subject to recall. 4. Utilizing the attached "Product Recall Acknowledgement Form", record the total number of individual impacted pieces. If you have no inventory remaining, please enter zero (0) on the form. 5. Return the completed "Product Recall Acknowledgement Form" to Aesculap, Inc. Product Quality Excellence department by emailing the form to PA OualityAssurance.BBMUS Service@bbraunusa.com or faxing the form to (610) 849-1197 within two weeks of receipt, even if the total inventory in your possession is zero (0). 6. Once Aesculap, Inc. receives your acknowledgement form, a customer support representative will contact you with instructions on how to return any impacted pieces in your possession. Complete the acknowledgment form. Included with letter Instructions for Identifying Affected MD610 etched as MD611.
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