Z-1469-2024 Class II Ongoing
FDA device recall Z-1469-2024 was initiated by Covidien, LP on Feb 28, 2024 and is designated Class II. Reason for recall: The potential for trocar seal disengagement when using mesh products incorrectly with the device. The recall status is ongoing. Affected quantity: 18,048 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 10, 2024
- Initiation Date
- Feb 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,048 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Republic Of, Luxembourg, Macao, Malaysia, Malta, Martinique, Mayotte, Mexico, Netherlands, New Caledonia, New Zealand, Nigeria, Northern Ireland, Norway, Oman, Poland, Portugal, Puerto Rico, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, United Kingdom, United States, Uzbekistan, Viet Nam, Virgin Islands, U.S.;
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1469-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026