Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 26, 2012
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.
Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Covidien LLC recalled HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) 540 Oakmead … - a moderate-severity action.
HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) 540 Oakmead … was recalled by Covidien LLC in September 26, 2012. Reason: Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore …. Check the official notice for the remedy. Verify recall #Z-2379-2012 with the FDA Devices before acting.
The recall
Covidien LLC issued this moderate-severity FDA Devices recall-Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore ….
- Moderate
- severity level
- Class II
- classification
- September 26, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2379-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2379-2012) was formally reported on September 26, 2012, with the manufacturer initiating the action on August 3, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Covidien LLC is listed as the recalling firm, operating out of Sunnyvale, CA. Federal records list the affected scope as 617 generators.
The documented reason for this recall is: Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care. Distribution data in the federal record shows the product reached: 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, Netherla…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
617 generators
Related Recalls
6
3 from same agency
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2379-2012 |
| Date reported | September 26, 2012 |
| Date initiated | August 3, 2012 |
| Recalling firm | Covidien LLC |
| Firm location | Sunnyvale, CA |
| Affected scope | 617 generators |
| Distribution | 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,… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2379-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Covidien LLC. Units affected: 617 generators.
Why was this product recalled? ▼
Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 26, 2012. Severity: Moderate. Recall number: Z-2379-2012.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2379-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 26, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.