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.

10101–10125 of 29157

  • 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
  • SevereFDA (Devices)·Z-1160-2020·2020-02-19

    Pacific Medical Loop-Style Tocotransducers Recalled for Unverified Service Components

    Pacific Medical Group is recalling Loop-Style Tocotransducers serviced with unverified non-OEM components, which may cause inaccurate fetal monitoring or patient burns.

    Product
    Loop-Style Tocotransducer (Nautilus) 2264LAX, 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 TOCO Cable Assem
    Category
    Medical Device
    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-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 (Drugs)·D-0845-2020·2020-02-19

    Efficient Laboratories Recalls Rompe Pecho CF Cold & Flu Due to Microbial Contamination

    Efficient Laboratories is recalling 5,249 bottles of Rompe Pecho CF Cold & Flu with Honey due to microbial contamination. The product was distributed nationwide in the USA.

    Product
    Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166.UPC 0 00856 33106 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V091000·2020-02-17

    Jayco Recalls Fifth Wheel Trailers Due to Underrated Axles

    Jayco is recalling 2013-2015 Fifth Wheel Seismic and 2015 Pinnacle trailers because they were built with 6,000lb axles instead of the intended 7,000lb axles.

    Product
    JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL, JAYCO SEISMIC, PINNACLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V090000·2020-02-14

    Mercedes-Benz Recalls G 550 and AMG G63 for Stability Control Defect

    Mercedes-Benz is recalling 2019-2020 G 550 and AMG G63 vehicles because a faulty electrical resistor may deactivate Electronic Stability Program and Anti-lock Brake System.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ G 550, AMG G63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V088000·2020-02-14

    Kia Recalls Sedona and Sorento Models for ABS Module Fire Risk

    Kia is recalling 2006-2010 Sedona and 2007-2009 Sorento vehicles because moisture in the ABS module can cause an electrical short and engine compartment fire.

    Product
    KIA — KIA SEDONA, SORENTO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V085000·2020-02-13

    Vermeer Recalls Brush Chipper Trailers Due to Lug Nut Defect

    Vermeer is recalling certain 2016-2020 brush chipper trailers because incorrect lug nuts may loosen, potentially causing the wheel to detach or loss of control.

    Product
    VERMEER — VERMEER BC1500, BC1000XL, BC1200XL, AX19
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V080000·2020-02-13

    RAM Recalls 2019 1500 Trucks for Transfer Case Defect

    Chrysler is recalling 2019 Ram 1500 4WD trucks because a transfer case gear may be installed incorrectly, potentially causing a sudden loss of power or loss of the Park function.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1004-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0976-2020·2020-02-12

    Cook Inc. Recalls Sof-Flex Ureteral Stent Sets Due to Loading Error

    Cook Inc. is recalling 13,388 Sof-Flex Multi-Length Ureteral Stent Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient.

    Product
    Sof-Flex Multi-Lenqth Ureteral Stent Set, Global Product No. G14773 G15000 G14867 G14951 G17852
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1020-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling specific surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1040-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0995-2020·2020-02-12

    Gore Excluder AAA Endoprosthesis Recalled for Catheter Separation

    W. L. Gore & Associates is recalling GORE EXCLUDER AAA Endoprosthesis devices due to reports of leading end catheter component separations.

    Product
    GORE¿ EXCLUDER¿ AAA Endoprosthesis
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1013-2020·2020-02-12

    Cardinal Health Recalls AAMI 3 Royalsilk Surgical Gowns Due to Contamination

    Cardinal Health is recalling AAMI 3 Royalsilk Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1002-2020·2020-02-12

    Cardinal Health Recalls AAMI 3 Fabric Reinforced Gowns Due to Contamination

    Cardinal Health is recalling AAMI 3 Fabric Reinforced Gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1011-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling AAMI 3 Royalsilk Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0635-2020·2020-02-12

    Pizza Hut Garlic Dipping Sauce Recalled for Metal Fragments

    Golden State Foods is recalling Pizza Hut Garlic Dipping Sauce due to metal fragments in a starch ingredient.

    Product
    Pizza Hut Garlic Dipping Sauce; 144 1.50 oz. cups Net Weight: 13.5 lbs. /6.12 kg Supplier ID: 0005320-01 GSF Product # 01918; Customer Product #: 0072917 Packed exclusively for use by Pizza Hut and its franchisees and licensees. Pizza hut, Plano, TX
    Category
    Food
    Distribution
    19 states
  • SevereNHTSA·20V075000·2020-02-12

    Forest River Recalls 2019-2020 Trailers Due to Spare Tire Carrier Defect

    Forest River is recalling 2019-2020 trailers because spare tire carrier U-bolts may fail, allowing the tire to detach and create a road hazard.

    Product
    FOREST RIVER — FOREST RIVER, COACHMEN INDEPENDENCE, R-POD, VIKING, PUMA
    Category
    Vehicle
    Distribution
    Distributed nationwide