Data Foundry

Medical device recalls 2024

Packaged — Class II medical device recall Z-0928-2024

Ongoing recall by AtriCure, Inc., reported 2024-02-07, distributed nationwide. AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect t

Recall numberZ-0928-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmAtriCure, Inc., Mason, OH, United States
Recall initiated2023-11-28
Classified2024-01-31
Reported by FDA2024-02-07
DistributedNationwide (US)
Countries outside the USBR, CA, JP, TW
Quantity1
UPC / GTIN / UDI-DI10840143903076
Lot numbers129675
Model numbersA001056

Product

Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056

Reason for recall

AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material.

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-0928-2024. 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.