Data Foundry

Medical device recalls 2023

Aesculap Surgical Needle — Class II medical device recall Z-2146-2023

Ongoing recall by Aesculap Implant Systems LLC, reported 2023-07-26, distributed nationwide. Incorrect product code marked on the product, etched with product code MD611, however; the correct product cod

Recall numberZ-2146-2023
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmAesculap Implant Systems LLC, Center Valley, PA, United States
Recall initiated2023-05-18
Classified2023-07-14
Reported by FDA2023-07-26
DistributedNationwide (US)
Quantity7 units
UPC / GTIN / UDI-DI04046963469054
Lot numbers22002834

Product

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

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2146-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.