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Covidien, LP recalls Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
Recalled April 10, 2024 · FDA recall Z-1466-2024 · Covidien
Hazard
The potential for trocar seal disengagement when using mesh products incorrectly with the device. · FDA Class II
Units
315,716 units
Sold at
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.;
Description
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Product
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
Manufacturer(s)
Covidien, LP
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →