RegWardenFDA facility compliance records
Facility

Breas Medical Ltd

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2014: 1 recalls1’14’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (1)

Devices registered here (1)

  • Device, Positive Pressure Breathing, Intermittent
    Product code NHJ (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5905

Recalls & enforcement

  • Class IITerminated2014-11-07
    Unintended treatment termination could result from a keypad malfunction in some situations. The device erroneously interprets this as a Stop Treatment Instruction. An alarm will not sound, or be registered. Accessories and monitoring equipment connected to the Vivo 50 will stop f…

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Breas Medical Ltd (FEI 3020562909) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3020562909-breas-medical-ltd/

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