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.

10076–10100 of 29157

  • SevereFDA (Food)·F-0681-2020·2020-02-19

    Market America Recalls Bliss Anti-Stress Formula Due to Undeclared Yohimbe

    Market America is recalling 1,496 bottles of bliss anti-stress formula dietary supplement due to potentially undeclared Yohimbe and reported adverse reactions.

    Product
    bliss anti-stress formula Dietary Supplement, 60 Tablets; Manufactured For and distributed by: Market America, Inc., 1302 Pleasant Ridge Road, Greensboro, NC 27409; UPC 8 48570 00470 3
    Category
    Food
    Distribution
    47 states
  • SevereFDA (Devices)·Z-1180-2020·2020-02-19

    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-05501-SH
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Drugs)·D-0852-2020·2020-02-19

    AuroMedics Recalls Amoxicillin and Clavulanate Potassium Tablets Due to Foreign Substance

    AuroMedics Pharma LLC is recalling 30,432 bottles of Amoxicillin and Clavulanate Potassium tablets because a customer complaint identified a nylon cable tie as a foreign substance.

    Product
    AMOXICILLIN AND CLAVULANATE POTASSIUM — AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (Drugs)·D-0833-2020·2020-02-19

    Taro Recalls Lamotrigine Tablets Due to Enalapril Maleate Contamination

    Taro Pharmaceuticals is recalling Lamotrigine Tablets 100 mg because they were cross-contaminated with enalapril maleate. The affected lot was distributed nationwide in the U.S. and Puerto Rico.

    Product
    LAMOTRIGINE — LAMOTRIGINE (LAMOTRIGINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1175-2020·2020-02-19

    Arrow International Recalls TheraCath Epidural Catheterization Kits

    Arrow International is recalling TheraCath Epidural Catheterization Kits because the included loss of resistance syringes may fail, potentially causing dural puncture.

    Product
    TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1174-2020·2020-02-19

    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-02220-SRH
    Category
    Medical Device
    Distribution
    37 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-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-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-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-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-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-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
  • SevereFDA (Devices)·Z-1177-2020·2020-02-19

    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 AK-05500
    Category
    Medical Device
    Distribution
    37 states
  • 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-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 (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 (Drugs)·D-0847-2020·2020-02-19

    Efficient Laboratories Recalls Rompe Pecho MAX Due to Microbial Contamination

    Efficient Laboratories, Inc. is recalling 4,080 bottles of Rompe Pecho MAX Multi Symptoms due to microbial contamination. Consumers should stop using the product and return it to the point of purchase.

    Product
    New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 00309 5
    Category
    Drug
    Distribution
    Distributed nationwide