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Covidien, LP recalls Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB

Recalled April 10, 2024 · FDA recall Z-1465-2024 · Covidien

Hazard
The potential for trocar seal disengagement when using mesh products incorrectly with the device. · FDA Class II
Units
124,863 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" Structural Balloon Trocar, Product Number OMS-T10SB
Manufacturer(s)
Covidien, LP

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Covidien, LP recalls Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB | RecallWatchUSA