ACUITY Universal Cutter — Class II medical device recall Z-0870-2021
Terminated recall by Boston Scientific Corporation, reported 2021-01-27, distributed nationwide. Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not underg
| Recall number | Z-0870-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2020-12-15 |
| Classified | 2021-01-15 |
| Reported by FDA | 2021-01-27 |
| Terminated | 2023-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 5 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 08714729936176 |
| Lot numbers | H1937249 |
| Model numbers | 7060 |
Product
ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.
Reason for recall
Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure.
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-0870-2021. 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.