The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. 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.

11751–11775 of 29163

  • SevereFDA (Drugs)·D-1479-2019·2019-07-17

    Riverpoint Pharmacy Recalls PAP/PHEN/PGE1 Injection Due to Sterility Concerns

    First Pharma Associates dba Riverpoint Pharmacy is recalling specific lots of PAP/PHEN/PGE1 Injection because the sterility of the product cannot be assured.

    Product
    PAP/PHEN/PGE1 22 mg/0.8mg/8mcg/mL Injection, 5mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1458-2019·2019-07-17

    Macleods Pharma Recalls Losartan Potassium Tablets Due to Impurity

    Macleods Pharma USA Inc. is recalling Losartan Potassium 50 mg tablets because an impurity was detected in the active ingredient.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1474-2019·2019-07-17

    FDA Recalls Hydroxyprogesterone Caproate Injection Due to Sterility Concerns

    First Pharma Associates is recalling Hydroxyprogesterone Caproate 250 mg/mL injections due to a lack of assurance of sterility. The recall affects vials distributed in Idaho and Washington.

    Product
    Hydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection, 5 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1478-2019·2019-07-17

    Methylcobalamin Injection Recalled for Lack of Sterility Assurance

    First Pharma Associates is recalling Methylcobalamin 10 mg/mL Injection vials due to a lack of assurance of sterility. The product was distributed in Idaho and Washington.

    Product
    Methylcobalamin 10 mg/mL Injection, 5.4 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1482-2019·2019-07-17

    Riverpoint Pharmacy Recalls PAP/PHEN/PGE1 Injection Due to Sterility Concerns

    First Pharma Associates dba Riverpoint Pharmacy is recalling specific lots of PAP/PHEN/PGE1 Injection due to a lack of assurance of sterility.

    Product
    PAP/PHEN/PGE1 18 mg/0.6mg/5.88mcg/mL Injection, 5 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1456-2019·2019-07-17

    Teva Recalls Losartan Potassium Tablets Due to Impurity Detection

    Teva Pharmaceuticals is recalling Losartan Potassium 100 mg tablets because an impurity was detected in the active ingredient.

    Product
    LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V535000·2019-07-17

    Volkswagen Recalls 2015-2016 CC and Tiguan for Air Bag Defect

    Volkswagen is recalling 27,822 2015-2016 CC and Tiguan vehicles because a defective air bag control unit may cause air bags to fail or deploy unexpectedly.

    Product
    VOLKSWAGEN — VOLKSWAGEN CC, TIGUAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1463-2019·2019-07-17

    Losartan Potassium tablets recalled due to impurity detection

    Golden State Medical Supply Inc. is recalling Losartan Potassium 50 mg tablets because an impurity was detected in the active ingredient.

    Product
    Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·073-2019·2019-07-13

    Ada Valley Recalls Raw Ground Beef Meatloaf Due to Metal Bits

    Ada Valley Gourmet Foods is recalling raw ground beef meatloaf products that may contain broken metal bits. The products were shipped to hospitals in Arizona, California, and Nevada.

    Product
    Ada Valley Gourmet Foods — Ada Valley Gourmet Foods, Inc. Recalls Beef Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·19V526000·2019-07-12

    Blue Bird Recalls School Buses Due to Roof Hatch Handle Defect

    Blue Bird is recalling 2018-2020 Vision and All American school buses because the roof emergency exit handle may break, preventing easy opening during an emergency.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN, VISION, VISION SCHOOL BUS, ALL AMERICAN SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V523000·2019-07-12

    Spartan Gladiator and MetroStar Front Shock Separation Recall

    Spartan is recalling 2014-2020 Gladiator and MetroStar vehicles because front shocks may separate, potentially causing a loss of power steering assist and increasing crash risk.

    Product
    SPARTAN — SPARTAN METROSTAR, GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V529000·2019-07-12

    American Coach Motorhomes Recalled for Rear Air Deflector Detachment Risk

    REV Recreation Group is recalling 2016-2019 American Coach motorhomes because rear air deflectors may detach, creating a road hazard.

    Product
    AMERICAN COACH — AMERICAN COACH AMERICAN HERITAGE, AMERICAN EAGLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V525000·2019-07-12

    Heartland Recalls Fifth-Wheel Trailers Due to A/C Electrical Connector Fire Risk

    Heartland is recalling specific 2016-2020 fifth-wheel trailers because an improperly installed A/C electrical connector may overheat and increase the risk of a fire.

    Product
    HEARTLAND — HEARTLAND PIONEER, NORTH PEAK, MILESTONE, ELKRIDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1945-2019·2019-07-10

    Bio-Detek Recalls ZOLL Pro-padz Liquid Gel Radiolucent Electrodes

    Bio-Detek, Inc. is recalling ZOLL Pro-padz Liquid Gel Radiolucent electrodes because some may be assembled incorrectly, preventing the delivery of defibrillation or pacing therapy.

    Product
    ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Food)·F-1588-2019·2019-07-10

    Ozark Country Sorghum Recalled Due to High Nitrate Levels and Illness Reports

    Ozark Country Kitchen is recalling sorghum jars due to high nitrate levels. Public health officials are investigating two cases of methemoglobinemia linked to the product.

    Product
    Sorghum, Mfg. by Ozark Country Sorghum, Dunnegan, MO 65640, Net Wt. 2 lb. 14 OZ. packaged in glass jars
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1924-2019·2019-07-10

    Draco Enzymatic Deep-Cleaning Pad Recalled for Bacterial Contamination

    Madison Polymeric Engineering is recalling Draco Enzymatic Deep-Cleaning Pads due to contamination with Stenotrophomonas lactiubi. The affected units were distributed to 13 US states.

    Product
    Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1905-2019·2019-07-10

    Siemens Fluoroscopic X-Ray Systems Recalled for Potential Screw Failure

    Siemens is recalling eight Artis fluoroscopic X-ray systems because screws on the ceiling-mounted support may loosen or snap, posing a risk of severe injury.

    Product
    Siemens Artis pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1894-2019·2019-07-10

    Siemens Artis zee X-Ray Systems Recalled for Ceiling Support Screw Failure

    Siemens is recalling 63 Artis zee X-ray systems because ceiling support screws may loosen or snap, posing a risk of severe injury to patients and staff.

    Product
    Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1897-2019·2019-07-10

    Siemens Artis X-Ray Systems Recalled for Ceiling Mount Screw Failure Risk

    Siemens is recalling 29 Artis X-ray systems because ceiling mount screws may loosen or snap, posing a risk of severe injury to patients and staff.

    Product
    Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V517000·2019-07-10

    Keystone Recalls 2020 Crossroads Trailers Due to Brake Wiring Defect

    Keystone is recalling 2020 Crossroads Hampton and Sunset trailers because an incorrectly wired breakaway switch may prevent brakes from functioning if the trailer separates from the tow vehicle.

    Product
    CROSSROADS — CROSSROADS HAMPTON, SUNSET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1896-2019·2019-07-10

    Siemens Artis X-Ray Systems Recalled for Ceiling Mount Screw Failure

    Siemens is recalling 120 Artis X-Ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury to patients and staff.

    Product
    Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Number: 10094141
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1898-2019·2019-07-10

    Siemens Artis X-Ray Systems Recalled for Ceiling Support Screw Failure

    Siemens is recalling 12 Artis X-ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury to patients and staff.

    Product
    Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System Model Number: 10848280
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1904-2019·2019-07-10

    Siemens Artis X-Ray Systems Recalled for Ceiling Mount Screw Failure Risk

    Siemens is recalling 11 Artis X-ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury to patients and staff.

    Product
    Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1895-2019·2019-07-10

    Siemens Artis zee Ceiling X-Ray System Recall for Loose Screws

    Siemens is recalling 276 Artis zee ceiling-mounted X-ray systems because screws joining the pivot bearing to the ceiling support may work loose or snap off, posing a risk of severe injury.

    Product
    Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System Model Number: 10094137
    Category
    Medical Device
    Distribution
    Distributed nationwide