Breas Medical, Inc.
Complete recall history across all FDA and CPSC categories — 5 total recalls
Breas Medical, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (5)
FDA medical device enforcement actions by Breas Medical, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Jul 25, 2024 | Vivo 45 LS, pressure and volume ventilator capable of delivering continuous o... | There is a potential for short term (<7 days) elevated levels of formaldehyde... | Class I |
| Oct 13, 2023 | with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 0060... | Produced with unintended open slits on the side of the mouthpiece body, may r... | Class II |
| Jun 2, 2022 | Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilat... | A forced shutdown of one of the processors did not generate a watch dog alarm... | Class II |
| Mar 21, 2022 | Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator mode... | Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator m... | Class II |
| Jan 28, 2020 | Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an ... | The outlet hole of the exhalation valve control pressure tube on the ventilat... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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