The Recall Desk

Hazard

Leak Failure recalls

2 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2
Critical
0
Severe
1
Most recent
2019-08-14

Of the 2 leak failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (50%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all leak failure recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–2 of 2

  • HighFDA (Devices)·Z-2136-2019·2019-08-14

    MED-EL Mi1000 Cochlear Implant Recall Due to Helium Leak Test Failures

    MED-EL is recalling seven Mi1000 CONCERTO cochlear implant devices because they were distributed despite failing helium-fine leak tests. The devices are intended for severely to profoundly hearing impaired individuals.

    Product
    MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi1000 CONCERTO PIN +FLEXsoft; d. Mil000 CONCERTO +Standard; e. Mil000 CONCERTO +Medium; f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1008-2015·2015-02-18

    Teleflex Recalls MAQUET Servo Humidifier 163 Due to Connector Cracks

    Teleflex is recalling 18 MAQUET Servo Humidifier 163 units because connector mount cracks may cause leaks, potentially depriving patients of adequate anesthetic gases.

    Product
    MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the t
    Category
    Medical Device
    Distribution
    4 states