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.

8501–8525 of 29123

  • SevereFDA (Devices)·Z-1228-2021·2021-03-17

    CervAlign Anterior Cervical Plate System Recall 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, 4Level, 60mm Material Number: 66-460 - 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-1239-2021·2021-03-17

    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, 5 Level, 80mm Material Number: 66-580 - 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
  • SevereNHTSA·21V183000·2021-03-17

    Braun Recalls Demers Ambulances Due to Sliding Seat Locking Pin Defect

    Braun Ambulances is recalling certain 2019-2021 Demers ambulances because the sliding attendant seat locking pin may fail, increasing injury risk in a crash.

    Product
    DEMERS AMBULANCES — DEMERS AMBULANCES MX170E FORD E-SERIES, TYPE I (MXP170E)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1211-2021·2021-03-17

    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, 24mm Material Number: 66-224 - 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-1209-2021·2021-03-17

    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, 1 Level, 20mm Material Number: 66-120 - 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-1208-2021·2021-03-17

    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, 1 Level, 18mm Material Number: 66-118 - 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-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-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-1222-2021·2021-03-17

    RTI Surgical 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, 3 Level, 48mm Material Number: 66-348 - 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-1217-2021·2021-03-17

    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, 2Level, 38mm Material Number: 66-238 - 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-1243-2021·2021-03-17

    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, 1 Level, 22mm Material Number: 66-122 - 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
  • 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-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-1227-2021·2021-03-17

    FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking 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, 3Level, 63mm Material Number: 66-363 - 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-1237-2021·2021-03-17

    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 surgical revision.

    Product
    CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material Number: 66-5105 - 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 o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1240-2021·2021-03-17

    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, 5 Level, 85mm Material Number: 66-585 - 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-1233-2021·2021-03-17

    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, 4Level, 80mm Material Number: 66-480 - 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-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-1207-2021·2021-03-17

    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, 1 Level, 16mm Material Number: 66-116 - 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-1204-2021·2021-03-17

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

    RTI Surgical is recalling 65 units 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, 10mm Material Number: 66-110 - 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
  • SevereNHTSA·21V182000·2021-03-17

    2021 Newmar Motorhomes Recalled for Missing Brake Pedal Return Spring

    Newmar is recalling 2021 New Aire, Dutch Star, and Ventana motorhomes because the brake pedal assembly may be missing a return spring. This can cause brake lights to stay on and brakes to remain engaged, increasing crash risk.

    Product
    NEWMAR — NEWMAR NEW AIRE, DUTCH STAR, VENTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0335-2021·2021-03-17

    Green City Distribution Recalls Al-Riyan Tuna Meat Due to High Histamine Levels

    Green City Distribution is recalling Al-Riyan Tuna Meat in Vegetable Oil because of high levels of histamines. The product was distributed in California, Michigan, Tennessee, and New York.

    Product
    Al-Riyan Tuna Meat in Vegetable oil 7 oz. can 48 cans per case
    Category
    Food
    Distribution
    4 states