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.

10051–10075 of 29157

  • SevereFDA (Drugs)·D-0840-2020·2020-02-19

    Kushim Tablets Recalled for Unapproved Active Ingredients

    B and A Trading Corporation is recalling 40 packages of Kushim Tablets marketed without FDA approval. Analysis found the product contains unapproved active ingredients.

    Product
    Kushim Tablets (Gushim) 45-count packages, Label in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1183-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Combined Spinal Epidural Catheterization Kits

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

    Product
    FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-TG1
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1203-2020·2020-02-19

    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 JC-05400-E
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Food)·F-0695-2020·2020-02-19

    ADM Milling Recalls H & R All Purpose Flour Due to E. coli O26 Risk

    ADM Milling is recalling 1,700 bags of H & R All Purpose Flour because of a potential E. coli O26 contamination. The product was distributed across 13 states.

    Product
    H & R All Purpose Flour MT/Product Code: 706205 in 50 lbs bags
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1163-2020·2020-02-19

    Pacific Medical External Toco Transducers Recalled for Unverified Components

    Pacific Medical Group is recalling 1,603 External Toco Transducers serviced with non-OEM parts that were not appropriately verified or validated.

    Product
    External Toco Transducer (M1355A), that may have been serviced with the following: Pacific Medical Philips M1355A Toco Bottom Case, NFPH9315; Pacific Medical Philips M1355A Toco Cable Assembly, NFPH9320; Pacific Medical Philips M1355A Toco Gauge, NFPH9340
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0688-2020·2020-02-19

    King Arthur All Purpose Flour Recalled Due to E. coli O26 Risk

    Adm Milling is recalling 11,074 bags of King Arthur All Purpose Flour due to potential E. coli O26 contamination. The recall covers 13 states.

    Product
    King Arthur All Purpose Flour 25# bags
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Food)·F-0700-2020·2020-02-19

    ADM Milling Recalls Sir Galahad Flour Due to E. coli O26 Risk

    ADM Milling is recalling 1,600 bags of Sir Galahad flour because it may be contaminated with E. coli O26. The recall covers 13 states.

    Product
    Sir Galahad flour / Product Code: 805226 in 50# bags
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1170-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Combined Spinal Epidural Catheterization Sets

    Arrow International Inc is recalling FlexTip Plus Combined Spinal Epidural Catheterization Sets because the included loss of resistance syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05400-B
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Food)·F-0699-2020·2020-02-19

    ADM Milling Recalls Potentate Flour Due to E. coli O26 Risk

    ADM Milling is recalling 7,400 bags of Potentate flour because it may be contaminated with E. coli O26. The recall covers distribution in 13 states.

    Product
    Potentate flour / Prod Code: 802217 in 50# bags
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Devices)·Z-0958-2020·2020-02-19

    Medtronic MiniMed 640G Insulin Pump Recall for Loose Reservoir Risk

    Medtronic is recalling specific 640G insulin pumps due to a loose reservoir that may cause incorrect insulin delivery.

    Product
    Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, and MMT-1752 *Not for US Distribution
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-1167-2020·2020-02-19

    Pacific Medical Ultrasound Transducers Recalled for Non-OEM Component Use

    Pacific Medical Group is recalling 5,897 ultrasound transducers serviced with unverified non-OEM components, which may cause inaccurate monitoring or patient burns.

    Product
    Ultrasound Transducer (M2736A), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips M2736A Avalon Smart Ultrasound Bottom Case, NFPHA9515
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1153-2020·2020-02-19

    Respironics V60 Ventilator User Interface Kits Recalled for Touchscreen Failure

    Respironics is recalling V60 Ventilator User Interface kits because the touchscreen may freeze, preventing clinicians from adjusting therapy settings.

    Product
    Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 453561528931, 453561528941, 453561536451, 453561536461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1172-2020·2020-02-19

    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 AK-05501
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1159-2020·2020-02-19

    Pacific Medical Group Recalls Button-Style Tocotransducers Due to Unverified Components

    Pacific Medical Group is recalling 9,679 Button-Style Tocotransducers serviced with non-OEM components that were not appropriately verified, posing risks of inaccurate monitoring and burns.

    Product
    Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Toco Board, NFCM9310; Pacific Medical GE Corometrics Nautilus TOCO Bottom Case, NFCM9315; Pacific Medical GE Corometrics Nautilus T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1161-2020·2020-02-19

    Pacific Medical Group Recalls Ultrasound Transducers Serviced with Non-OEM Parts

    Pacific Medical Group is recalling 6,481 Button-Style Ultrasound Transducers serviced with unverified non-OEM components. The defect may cause inaccurate fetal and maternal monitoring or patient burns.

    Product
    Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE Corometrics Nautilus Ultrasound Bottom Case, NFCM9515, Pacific Medical GE Cor
    Category
    Medical Device
    Distribution
    Distributed nationwide