Z-2146-2023Class II

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

Name: Z-2146-2023 Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article...
Creator: Aesculap Implant Systems LLC
Published: 2023-05-18
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2023-05-18 / Open, Classified / root cause: labeling and UDI

FDA source

Aesculap Implant Systems LLC began a recall of Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610 on 2023-05-18. FDA classified it as Class II and gives the reason as "Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2146-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-18
Posted: 2023-07-14
Recalling firm: Aesculap Inc
Product: Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
Product code: HXK Holder, Needle; Orthopedic
Reason for recall: Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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 [email protected] 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.
Quantity in commerce: 7 units
Distribution: US Nationwide distribution in the states of DC, MO, PA, TX.
Product codes and lots: GUIDID: 04046963469054 Lot Number: 22002834

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2146-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2146-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-14

Product code HXK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)