Class II

Medical Device Recall: Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL

Covidien, LP · February 28, 2024

Reason for Recall

The potential for trocar seal disengagement when using mesh products incorrectly with the device.

Distribution

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.;

States Affected

NATIONWIDE

Quantity Affected

44,777 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1471-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Covidien, LP Medical Device Recall: Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL | SafeCheck