Data Foundry

Medical device recalls 2025

ECHELON LINEAR Cutters Reload 80 mm Blue — Class II medical device recall Z-0147-2026

Ongoing recall by Ethicon Endo-Surgery Inc, reported 2025-10-22. The devices were shipped unsterilized.

Recall numberZ-0147-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmEthicon Endo-Surgery Inc, Blue Ash, OH, United States
Recall initiated2025-09-11
Classified2025-10-14
Reported by FDA2025-10-22
Countries outside the USAE
Quantity3 units
UPC / GTIN / UDI-DI10705036030881
Lot numbers904C12

Product

ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80

Reason for recall

The devices were shipped unsterilized.

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-0147-2026. 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.