The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

8476–8500 of 29123

  • SevereNHTSA·21V190000·2021-03-18

    Damaged Third-Row Seat Belts in 2021 GM Full-Size SUVs

    General Motors is recalling 2021 full-size SUVs because third-row seat belts may be entrapped or misrouted behind the seat-folding mechanism, potentially becoming damaged. A damaged seat belt could break during a crash, increasing the risk of occupant injury.

    Product
    GMC — GMC, CADILLAC, CHEVROLET YUKON, ESCALADE, SUBURBAN, ESCALADE ESV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V191000·2021-03-18

    Arcimoto Recalls FUV and Deliverator Vehicles Due to Battery Shutdown Risk

    Arcimoto is recalling 2019-2020 FUV and 2020 Deliverator vehicles because high-voltage contactors may overheat, causing unexpected battery shutdowns and loss of motive power.

    Product
    ARCIMOTO — ARCIMOTO FUV, DELIVERATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V189000·2021-03-18

    GM Recalls 2021 Chevrolet Express and GMC Savana for Fire Risk

    General Motors is recalling 2021 Chevrolet Express and GMC Savana vans with 6.6L engines because a battery cable defect may cause a short circuit and fire.

    Product
    CHEVROLET — CHEVROLET, GMC EXPRESS, SAVANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·21098·2021-03-18

    HD Hudson Recalls illu-Mist Battery-Powered Garden Sprayers Due to Fire Hazard

    HD Hudson is recalling illu-Mist battery-powered garden sprayers because the lithium-ion battery can overheat and catch fire. Consumers should stop using the sprayers and contact the company for a replacement.

    Product
    illu-Mist Battery-Powered Garden Sprayers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1215-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 34mm Material Number: 66-234 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1201-2021·2021-03-17

    Medtronic Recalls Valiant Navion Thoracic Stent Grafts Due to Structural Defects

    Medtronic is recalling 33,430 Valiant Navion Thoracic Stent Graft Systems worldwide due to endoleaks, stent fractures, and ring enlargement.

    Product
    Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1242-2021·2021-03-17

    CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 95mm Material Number: 66-595 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1235-2021·2021-03-17

    RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 88mm Material Number: 66-488 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1223-2021·2021-03-17

    RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure

    RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 51mm Material Number: 66-351 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1210-2021·2021-03-17

    RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure

    RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 24m Material Number: 66-124 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1206-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 14mm Material Number: 66-114 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1214-2021·2021-03-17

    CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 32mm Material Number: 66-232 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1218-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 40mm Material Number: 66-240 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1185-2021·2021-03-17

    Brainlab ExacTrac Dynamic Radiation Therapy System Software Recall

    Brainlab AG is recalling ExacTrac Dynamic radiation therapy systems due to a software error that may allow treatment despite exceeding position tolerances.

    Product
    ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-1225-2021·2021-03-17

    RTI Surgical Recalls CervAlign Anterior Cervical Plate System

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 57mm Material Number: 66-357 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1229-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 64mm Material Number: 66-464 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1234-2021·2021-03-17

    RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate during or after surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 84mm Material Number: 66-484 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1241-2021·2021-03-17

    CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure

    RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 90mm Material Number: 66-590 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1216-2021·2021-03-17

    CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 36mm Material Number: 66-236 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1246-2021·2021-03-17

    Medtronic Guide Catheter Recalled Due to Potential Sterility Compromise

    Medtronic Vascular is recalling 9 units of 6F Launcher Guide Catheters because unsealed pouches may compromise sterility.

    Product
    Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1212-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 26mm Material Number: 66-226 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1205-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 12mm Material Number: 66-112 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1220-2021·2021-03-17

    RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure

    RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 42mm Material Number: 66-342 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1230-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

    RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 68mm Material Number: 66-468 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
    Category
    Medical Device
    Distribution
    Distributed nationwide