FDA Recalls HALO Flex Energy Generators Due to Standby Mode Failure
The FDA is recalling HALO Flex Energy Generators because they may fail to enter standby mode upon startup, rendering them unusable for patient care.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a functional failure that renders the device unusable rather than a defect causing injury or death. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary measures where no harm is reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for HALO Flex Energy Generators manufactured by BARRX Medical (now Covidien). The recall involves 617 units of the device, which is indicated for the coagulation of soft tissue and bleeding sites in the gastrointestinal tract.
The recall was initiated because the energy generators have the potential to fail to enter "stand by" mode when initially powered on. This specific failure mode prevents the device from being used for patient care. The affected units include model numbers 1190A-115A and 1190A-230A with all serial numbers.
The devices were distributed worldwide, including nationwide in the United States and in numerous international markets such as Argentina, Australia, Canada, and the United Kingdom. Healthcare facilities and users should stop using the affected devices and contact the recalling firm, Covidien LLC, for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Covidien LLC
- Affected units
- 617
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model numbers 1190A-115A and 1190A-230A
- all serial numbers.
Distribution
Distributed nationwide across the United States.
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