The Recall Desk
ModerateFDA (Devices)·Z-2146-2023·Announced 2023-07-26

Aesculap Surgical Needle Recalled for Incorrect Product Code Marking

Aesculap Implant Systems is recalling Aesculap Surgical Needles (MD610) because they are etched with an incorrect product code. The needles are marked MD611 when they should be marked MD610.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a minor labeling error where the product code etched on the device is incorrect. No illnesses, injuries, or complications have been reported. The issue is product identification marking related rather than a functional safety hazard.

Plain-English summary

Aesculap Implant Systems LLC is recalling Aesculap Surgical Needles, straight, 3.5 inches (90 mm), 13GA, non-sterile and reusable, Article Number MD610. The recall affects 7 units distributed nationwide in the states of District of Columbia, Missouri, Pennsylvania, and Texas. The recalled lot number is 22002834.

The product code is incorrectly marked on the needles. The devices are etched with product code MD611; however, the correct product code should be MD610. This marking discrepancy could lead to confusion regarding product identification.

If you have received or used these needles, verify the product code against your records to determine if you have affected units. Contact Aesculap Implant Systems LLC for guidance on handling of affected devices. No injuries or complications related to this issue have been reported.

The recalled product

Product
Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
Manufacturer
Aesculap Implant Systems LLC
Hazard
  • mislabeling
  • product-identification

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • GUIDID: 04046963469054 Lot Number: 22002834

Distribution

Distributed nationwide across the United States.