HALO Flex Energy Generators Manufactured by B¿RRX Medical — Class II medical device recall Z-2379-2012
Terminated recall by Covidien LLC, reported 2012-09-26, distributed nationwide. Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore c
| Recall number | Z-2379-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, Sunnyvale, CA, United States |
| Recall initiated | 2012-08-03 |
| Classified | 2012-09-14 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2013-09-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, CA, CH, CL, CO, CZ, DE, DK, ES, FR, GB, GR, HU, IL, IN, JO, NL, NO, PL, PT, SA, SE, TW, VE, ZA |
| Quantity | 617 generators |
| Model numbers | 1190A-115A, 1190A-230A |
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 bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus, including Barrett's Esophagus.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2379-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.