The Recall Desk

Manufacturer

Ossur H / F

29 recalls in our database name Ossur H / F as the manufacturing or recalling firm.

What the numbers show

Total
29
Critical
0
Severe
1
Most recent
2024-10-09

Of the 29 recalls from Ossur H / F we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (3%) 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.

1–25 of 29

  • HighFDA (Devices)·Z-0006-2025·2024-10-09

    Miami J Select Collar Recalled Due to Adhesive Failure

    Ossur is recalling Miami J Select Collars due to pressure-sensitive adhesive hooks that may peel off during repeated use, potentially reducing cervical spine immobilization effectiveness.

    Product
    Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-1790-2024·2024-05-22

    Prosthetic Knee Firmware Defect Risks Unintended Shutdown and Patient Falls

    The RKNXC0005 RHEO KNEE XC prosthetic knee may experience firmware issues causing unintended warnings and device shutdown, creating a fall risk for patients.

    Product
    RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1788-2024·2024-05-22

    Prosthetic knee recalled due to firmware defect causing device shutdown

    Ossur RHEO KNEE prosthetic units recalled due to firmware issues causing unintended warnings and device shutdown, which could result in patient falls.

    Product
    RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1789-2024·2024-05-22

    Ossur RHEO Knee XC Prosthetic Components Recall Due to Firmware Issues

    Ossur is recalling 107 RHEO Knee XC prosthetic components due to firmware issues that may cause unintended device shutdown or warnings, risking patient falls.

    Product
    RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1787-2024·2024-05-22

    Prosthetic knee recalled due to firmware issues causing potential device shutdown

    Ossur H/F is recalling RHEO KNEE prosthetic knee components due to firmware issues that could cause unintended warnings and device shutdown, creating fall risk for users.

    Product
    RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0788-2024·2024-01-31

    Power Knee Prosthetic Batteries Recalled Due to Unexpected Shutdown Risk

    Ossur Power Knee prosthetic knee batteries may fail to turn on or shut down unexpectedly, potentially causing users to lose support and fall. Affected units are distributed nationwide.

    Product
    Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1906-2023·2023-06-21

    Prosthetic Socket Ratchet Locking Systems Recalled for Suspension Loss Risk

    Mechanical locking devices for prosthetic sockets may develop accelerated wear that causes the attachment pin to disengage, potentially leading to loss of prosthetic suspension and falls.

    Product
    Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption Kit, REF: L-621100; Ratchet Lock Body, REF: L-692020
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1515-2016·2016-04-27

    Ossur Lil Angel Vest Recalled for Potential Plastic Strap Fracture

    Ossur H / F is recalling Lil Angel Vest P3 Sorbatex units because the plastic stabilizer strap may partially or completely fracture.

    Product
    Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1513-2016·2016-04-27

    Ossur Lil Angel Vest Recalled for Potential Plastic Strap Fracture

    Ossur H / F is recalling Lil Angel Vest P3 Kodel units due to a potential for partial or complete fracture of the plastic stabilizer strap.

    Product
    Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1511-2016·2016-04-27

    Ossur Lil Angel Vest Recalled for Potential Plastic Strap Fracture

    Ossur H / F is recalling Lil Angel Vest P2 Lambswool units because the plastic stabilizer strap may partially or completely fracture.

    Product
    Ossur Lil Angel Vest P2 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1510-2016·2016-04-27

    Ossur Lil Angel Vest P2 Kodel Recalled for Potential Plastic Strap Fracture

    Ossur H / F is recalling 435 Lil Angel Vest P2 Kodel units due to a potential for partial or complete fracture of the plastic stabilizer strap.

    Product
    Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1512-2016·2016-04-27

    Ossur Lil Angel Vest Recalled Due to Potential Plastic Strap Fracture

    Ossur H / F is recalling Lil Angel Vest P2 Sorbatex pediatric vests because the plastic stabilizer strap may partially or completely fracture.

    Product
    Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1514-2016·2016-04-27

    Ossur Lil Angel Vest Recalled for Potential Plastic Strap Fracture

    Ossur H / F is recalling Lil Angel Vest P3 Lambswool units because the plastic stabilizer strap may fracture. The recall covers 435 units distributed in the US and Hong Kong.

    Product
    Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1296-2016·2016-04-06

    Ossur Recalls Multiple Medical Devices Including Knee Braces and Walkers

    Ossur Americas is recalling various medical devices, including knee braces and walkers, due to unspecified product issues.

    Product
    Unloader Custom Product Usage: Unloader Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1286-2016·2016-04-06

    Ossur Recalls Multiple Medical Devices Including Knee Undersleeves and Walkers

    Ossur Americas is recalling various medical devices, including knee undersleeves and walkers, due to a defect described in the source text.

    Product
    Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for comfort under knee braces.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1289-2016·2016-04-06

    Ossur Recalls Rebound Cartilage Knee Braces and Other Medical Devices

    Ossur Americas is recalling Rebound Cartilage knee braces and other medical devices due to a defect described in the source text.

    Product
    Rebound Cartilage Product Usage: Rebound Cartilage is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1287-2016·2016-04-06

    Ossur Recalls NecLoc Extrication Collars and Other Medical Devices

    Ossur Americas is recalling NecLoc Extrication Collars and other medical devices due to a defect described as 'the p'.

    Product
    NecLoc Extrication Collar Product Usage: Necloc collars are applied to patients afflicted with cervical injuries to ensure immobilization.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1288-2016·2016-04-06

    Ossur Recalls Multiple Medical Devices Including Miami J Collars

    Ossur Americas is recalling various medical devices, including Miami J collars and knee shields, due to a manufacturing defect.

    Product
    Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1295-2016·2016-04-06

    Ossur Recalls Multiple Orthopedic Braces and Medical Devices

    Ossur Americas is recalling various orthopedic braces and medical devices, including the Unloader Custom Lite, due to a defect described in the source text.

    Product
    Unloader Custom Lite Product Usage: Unloader Custom Lite is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1293-2016·2016-04-06

    Ossur Recalls Multiple Medical Devices Including Back Support Suspenders

    Ossur Americas is recalling various medical devices, including back support suspenders, due to a defect described in the source text.

    Product
    Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1292-2016·2016-04-06

    Ossur Recalls Rebound Diabetic Walkers and Other Medical Devices

    Ossur Americas is recalling Rebound Diabetic Walkers and other medical devices due to a defect described as 'the p'.

    Product
    Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1298-2016·2016-04-06

    Ossur Recalls Papoose Infant Spine Immobilizers and Other Medical Devices

    Ossur Americas is recalling Papoose Infant Spine Immobilizers and other orthopedic devices due to a defect described as 'the p'.

    Product
    Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO front POR-100 Papoose w/o PO front w/pad Product Usage: The Papoose Infant Immobilizer is an external class I orthotic device used to secure
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1291-2016·2016-04-06

    Ossur Recalls Rebound Air Walkers and Other Medical Devices

    Ossur Americas is recalling Rebound Air Walkers and other medical devices due to a defect described as 'the p'.

    Product
    Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to stabilize fractures, post-operative use, and trauma or rehab use.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1290-2016·2016-04-06

    Ossur Recalls Multiple Orthopedic Braces and Medical Devices

    Ossur Americas is recalling various orthopedic braces and medical devices, including knee braces and back supports, due to a defect described as 'the p'.

    Product
    Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1294-2016·2016-04-06

    Ossur Recalls Multiple Orthopedic Braces and Medical Devices

    Ossur Americas is recalling various orthopedic braces and medical devices due to unspecified product defects.

    Product
    Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Medical Device
    Distribution
    48 states