The Recall Desk

Manufacturer

Bien-Air Surgery Sa

5 recalls in our database name Bien-Air Surgery Sa as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
4
Most recent
2020-10-28

Of the 5 recalls from Bien-Air Surgery Sa we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (80%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • SevereFDA (Devices)·Z-0180-2021·2020-10-28

    Entellus Medical Shaver System Foot Pedal Recalled for Magnet Defect

    Bien-Air Surgery Sa is recalling Entellus Medical Shaver System foot pedals because an internal magnet may detach, causing the motor to start unattended and become unstoppable.

    Product
    Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0179-2021·2020-10-28

    Stryker S2 Mini Foot Pedal Recalled Due to Magnet Defect

    Bien-Air Surgery is recalling Stryker S2 Mini Foot Pedals because an internal magnet may detach, causing the motor to start unattended and become unstoppable.

    Product
    Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty. The S2 Mini Drill System consists of a foot ped
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0176-2021·2020-10-28

    Bien-Air Surgery Foot Pedal Recalled Due to Magnet Detachment Risk

    Bien-Air Surgery is recalling 1,120 foot pedals because an internal magnet may detach, causing the motor to start unattended and become unstoppable.

    Product
    Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0177-2021·2020-10-28

    Bien-Air Surgery Multifunction Pedal Recalled Due to Magnet Failure Risk

    Bien-Air Surgery is recalling 1,120 OsseoDuo multifunction foot pedals because an internal magnet may detach, causing the motor to start unattended and become unstoppable.

    Product
    Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforator tools for cutting and shaping bone including spi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0178-2021·2020-10-28

    Bien-Air Surgery OSSEOSTAP Footcontrol Recalled for Magnet Defect

    Bien-Air Surgery is recalling OSSEOSTAP foot pedals because an internal magnet may detach, causing the motor to start unattended and become unstoppable.

    Product
    Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide