Covidien LLC: Medical Device Recall in 2012 - (Recall #: Z-2379-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The HALO Flex Energy Generator is indicated for use for the coagulation of soft tissue. The HALO Flex System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus, including Barrett's Esophagus.

Product Classification:

Class II

Date Initiated: August 3, 2012

Date Posted: September 26, 2012

Recall Number: Z-2379-2012

Event ID: 62867

Reason for Recall:

Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care.

Status: Terminated

Product Quantity: 617 generators

Code Information:

Model numbers 1190A-115A and 1190A-230A; all serial numbers.

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Israel, Jordan, Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Venezuela and UK.

Voluntary or Mandated:

Voluntary: Firm initiated