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.

13651–13675 of 29188

  • SevereFDA (Food)·F-1946-2018·2018-09-12

    Fresh Express Recalls Chopped Romaine Due to Cyclospora Test Result

    Fresh Express is recalling 482 cases of Chopped Romaine 1 lb after a test detected the Cyclospora organism. The product was distributed in 15 U.S. states.

    Product
    Fresh Express Chopped Romaine 1 lb
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Devices)·Z-2960-2018·2018-09-12

    Bayer Overhead Counterpoise Systems Recalled for Potential Structural Failure

    Bayer Medical Care is recalling two Overhead Counterpoise Systems because overtightened bolts may compromise structural integrity, posing a risk of injury.

    Product
    Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253
    Category
    Medical Device
    Distribution
    3 states
  • SevereNHTSA·18V618000·2018-09-12

    Jayco Recalls 2019 Travel Trailers Due to Missing Axle Bearing Races

    Jayco is recalling 2019 White Hawk, Jay Flight, and Jay Flight SLX travel trailers because missing inner bearing races may cause hub overheating and axle separation.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER JAY FLIGHT SLX, JAY FLIGHT, WHITE HAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V612000·2018-09-11

    Ford Recalls 2018 Edge and Lincoln MKX for Door Striker Bolt Defect

    Ford is recalling 2018 Ford Edge and Lincoln MKX vehicles because shorter-than-intended door striker bolts may cause doors to open in a crash, increasing injury risk.

    Product
    FORD — FORD, LINCOLN EDGE, MKX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V608000·2018-09-11

    Mercedes-Benz Recalls 2018 C-Class Models Due to Rear Window Bonding Defect

    Mercedes-Benz is recalling 2018 C300, C300 4MATIC, C63 AMG, and C63S AMG vehicles because incorrect rear window bonding may cause the glass to detach, creating a road hazard.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, MERCEDES BENZ AMG C63S, C 300 4MATIC, C 300, AMG C63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V585000·2018-09-08

    Trailstar Recalls 2019 Dump Trailers Due to Wheel Separation Risk

    Trailstar is recalling 2019 Dump trailers because improperly installed wheel end nuts may cause the wheel to separate from the axle, increasing crash risk.

    Product
    TRAILSTAR — TRAILSTAR DUMP TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V595000·2018-09-07

    GM Recalls 2014-2016 Cadillac CTS for Seat Heater Fire Risk

    General Motors is recalling 2014-2016 Cadillac CTS vehicles because damaged front seat heaters may overheat and cause a fire when the car is remotely started.

    Product
    CADILLAC — CADILLAC CTS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V598000·2018-09-07

    Navistar Recalls 2019 IC Bus School Buses Due to Brake Defect

    Navistar is recalling 2019 IC Bus CE and RE school buses because a parking brake component may be improperly crimped, causing air leaks and increased stopping distances.

    Product
    IC BUS — IC BUS CESB, RESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V597000·2018-09-07

    Navistar Recalls 2019 International and IC Bus Vehicles for Brake Defect

    Navistar is recalling 2,089 2019 International and IC Bus vehicles because a brake chamber defect may cause air leaks, increasing stopping distance and crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL, IC BUS LT, HX, WORKSTAR, DURASTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V599000·2018-09-07

    Honda Recalls 2017 Acura NSX for Brake Light Circuit Defect

    Honda is recalling 793 2017 Acura NSX vehicles because road vibrations may loosen screws, causing the center brake light to fail and increasing crash risk.

    Product
    ACURA — ACURA NSX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V601000·2018-09-07

    Nissan Recalls Murano, Maxima, Pathfinder, and QX60 for Brake Fire Risk

    Nissan is recalling specific 2015-2018 Murano, Maxima, Pathfinder, and 2017 QX60 vehicles because brake fluid leaks may cause electrical shorts and fires.

    Product
    NISSAN — NISSAN, INFINITI MURANO, QX60, MAXIMA, PATHFINDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1162-2018·2018-09-05

    Auro Pharmacies Recalls Methyl-Cobalamin Injectable Due to Sterility Concerns

    Auro Pharmacies is recalling 81 vials of Methyl-Cobalamin injectable because processes and equipment were inadequate to assure sterility.

    Product
    Methyl-Cobalamin injectable, 10 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2951-2018·2018-09-05

    Haemonetics OrthoPAT Reservoirs Recalled Due to Missing Cannula

    Haemonetics is recalling 348 OrthoPAT QuickConnect Reservoirs because a missing cannula prevents blood from being emptied and processed.

    Product
    Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs. Product Code: OPT-R-1000 The OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1143-2018·2018-09-05

    Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling specific batches of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-327-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1140-2018·2018-09-05

    Torrent Pharma Recalls Amlodipine and Valsartan Tablets Due to Carcinogen Impurity

    Torrent Pharma Inc. is recalling specific batches of Amlodipine and Valsartan Tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-207-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V590000·2018-09-05

    Fabform Recalls 2017-2018 Power Tilt Dump Trailers Due to Hinge Fracture Risk

    Fabform is recalling 2017-2018 Power Tilt dump trailers because welded hinges may fracture, causing the dump box to fall unexpectedly and increasing the risk of injury or death.

    Product
    FABFORM — FABFORM POWER TILT DUMP TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1147-2018·2018-09-05

    Pharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

    Pharmcore Inc. is recalling 5,718 vials of Human Chorionic Gonadotropin 5000 IU due to a lack of assurance of sterility.

    Product
    Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1163-2018·2018-09-05

    Auro Pharmacies Recalls Testosterone Injectable Due to Sterility Concerns

    Auro Pharmacies is recalling 43 vials of Testosterone Cypionate/Enanthate injectable because inadequate processes and equipment failed to assure product sterility.

    Product
    Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1156-2018·2018-09-05

    Auro Pharmacies Recalls CoEnzyme-Q10 Injectable Due to Sterility Concerns

    Auro Pharmacies is recalling 39 vials of CoEnzyme-Q10 injectable because inadequate processes and equipment failed to assure product sterility.

    Product
    CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1138-2018·2018-09-05

    Torrent Pharma Recalls Amlodipine and Valsartan Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Amlodipine and Valsartan Tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-205-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2926-2018·2018-09-05

    Stanbio AC Power Adapter Recall for HemoPoint H2 Meter

    Stanbio Laboratory is recalling AC power adapters for the HemoPoint H2 meter because the adapter plate may crack or detach, exposing live electrical contacts.

    Product
    Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1149-2018·2018-09-05

    Pharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

    Pharmcore Inc. is recalling 355 vials of Human Chorionic Gonadotropin 20000 IU due to a lack of assurance of sterility.

    Product
    Human Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
    Category
    Drug
    Distribution
    Distributed nationwide