Ethicon Sarl, a Johnson & Johnson Company: Device Recall

Recall #Z-2406-2024 · 06/11/2024

Class II: Risk

Recall Details

Recall Number: Z-2406-2024
Classification: Class II
Product Type: Device
Recalling Firm: Ethicon Sarl, a Johnson & Johnson Company
Status: Ongoing
Date Initiated: 06/11/2024
Location: Neuchatel, Switzerland
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 450,793 units (65,950 US, 384,843 OUS)

Reason for Recall

Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.

Product Description

SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of India and Japan.

Other Recalls by Ethicon Sarl, a Johnson & Johnson Company

Class II: Risk 06/11/2024

Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.

View all recalls by Ethicon Sarl, a Johnson & Johnson Company →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.