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.

10026–10050 of 29157

  • SevereNHTSA·20E006000·2020-02-20

    Meritor Recall: Insufficient Lubrication in Specific Steer Axles

    Meritor is recalling specific steer axles due to insufficient lubrication that may damage wheel end bearings. This defect could cause the wheel to separate, leading to a loss of vehicle control.

    Product
    POWER TRAIN:AXLE ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1196-2020·2020-02-19

    Arrow International Recalls Pediatric Epidural Catheterization Sets Due to Syringe Failure Risk

    Arrow International is recalling FlexTip Plus Epidural Catheterization Sets for pediatric lumbar placement because the included loss of resistance syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Set for Pediatric Lumbar Placement, Product Code EC-05520-P
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1156-2020·2020-02-19

    Medicrea TLIF-B Holder Recalled Due to Potential Rod Separation

    Medicrea International is recalling 14 units of TLIF-B Holders because the inner draw rod may separate from the knob.

    Product
    Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1117-2020·2020-02-19

    Teleflex Recalls Rusch Greenlite Laryngoscope Blades Due to Breakage Reports

    Teleflex Medical Inc. is recalling Rusch Greenlite Single-Use Metal Laryngoscope Blades because they may break at a welded joint during setup or use.

    Product
    Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1201-2020·2020-02-19

    Arrow FlexTip Plus Epidural Catheterization Set Recalled for Syringe Failures

    Arrow International is recalling FlexTip Plus Epidural Catheterization Sets because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-B
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1176-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05500-TM
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1116-2020·2020-02-19

    Teleflex Recalls Rusch Greenlite Laryngoscope Blades Due to Breakage Reports

    Teleflex Medical is recalling Rusch Greenlite Single-Use Metal Laryngoscope Blades because they may break at a welded joint during setup or use.

    Product
    Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1179-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Food)·F-0698-2020·2020-02-19

    ADM Milling Recalls Polar Bear Flour Due to E. coli O26 Risk

    ADM Milling is recalling 200 bags of Polar Bear Flour UNTR because it may be contaminated with E. coli O26. The product was distributed to 13 states.

    Product
    Polar Bear Flour UNTR /Prod Code: 710200 in 50# bags
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1212-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code TI-05501-ME
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1166-2020·2020-02-19

    Pacific Medical Toco+ Transducers Recalled for Unverified Service Components

    Pacific Medical Group is recalling 2,170 Toco+ transducers serviced with unverified non-OEM components. The defect may cause inaccurate fetal/maternal monitoring and patient burns.

    Product
    Toco+ transducer with ECG/IUP capability (wired), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips Avalon Smart M2734A/2735A Toco Gauge Flex, NFPHA9341
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1111-2020·2020-02-19

    Terumo Advanced Perfusion Assembly Pump Guts Recalled for Potential Shaft Failure

    Terumo is recalling 11 Advanced Perfusion Assembly Pump Guts units because pump shafts may fail, potentially causing the pump to stop during surgery.

    Product
    Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualifi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1223-2020·2020-02-19

    Microvention AZUR Peripheral Coil System Recall for Missing Implant Coil

    Microvention is recalling 392 units of AZUR Peripheral Coil Systems because the implant coil may be missing from the devices.

    Product
    Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers 45-451015, 45-451020, 45-451215, 45-451220, 45-451230, 45-451520, 45-451530, 45-452020, 45-452030, 45-450410, 45-450415, 45-450405, 45-450610, 45-450615, 45-450620, 45-450815, 4
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1193-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits due to potential syringe failures that could cause dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code CA-02220
    Category
    Medical Device
    Distribution
    37 states