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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 7
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
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