RecallRadar

FDA Device recall Z-2146-2023

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

On 2023-07-26 the FDA classified a Class II recall of Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610 by Aesculap Implant Systems, citing incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2146-2023
ClassificationClass II
Statusongoing
Initiated2023-05-18
Published2023-07-26
Last updated2026-09-13 11:56 UTC
CompanyAesculap Implant Systems
DistributionUS

Product

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

Reason

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

Identifiers

code_infoGUIDID: 04046963469054 Lot Number: 22002834

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2146-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.