FDAClass IIJuly 26, 2023

Aesculap Surgical Needle recall

Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610

Why was Aesculap Surgical Needle recalled?

Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

GUIDID: 04046963469054 Lot Number: 22002834

Product
Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
Recalling firm
Aesculap Implant Systems LLC
Quantity
7 units
Distribution
US Nationwide distribution in the states of DC, MO, PA, TX.
Recall date
July 26, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls