Product Wiki · Recalls · U.S. FDA — Device Enforcement

JAGTOME RX 39-30-260-025 Material Number: M00573100 — recall Z-0770-2022

U.S. FDA — Device Enforcement · United States · 2021-12-22 · Class II

As described by U.S. FDA — Device Enforcement: JAGTOME RX 39-30-260-025 Material Number: M00573100

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0770-2022
Date of alert
2021-12-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Boston Scientific Corporation
Product category
device
Product type
Devices
Recall status
Ongoing — the recall is still in progress
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand,
Barcode (EAN/GTIN)
27465196
Reported risk: Sterility of device is compromised due to a sterile barrier breach
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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