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.

14426–14450 of 29192

  • SevereFDA (Drugs)·D-0804-2018·2018-05-09

    Sanofi Recalls Over-Concentrated Docetaxel Injection Vials Nationwide

    Sanofi-Aventis is recalling 19,580 vials of Docetaxel injection concentrate due to potential over-concentration. The affected lots were distributed nationwide.

    Product
    DOCETAXEL — DOCETAXEL (DOCETAXEL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0704-2018·2018-05-09

    AuroMedics Recalls Levofloxacin IV Bags Due to Sterility Concerns

    AuroMedics Pharma LLC is recalling specific lots of Levofloxacin in 5% Dextrose Injection due to a lack of assurance of sterility and a confirmed report of leaking bags with mold.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN IN 5% DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1199-2018·2018-05-09

    Target Market Pantry Chicken Tail Off Recall Due to Temperature Issues

    Target is recalling Market Pantry Chicken Tail Off products purchased in Honolulu, Hawaii, because a shipping container was not held at the proper temperature.

    Product
    MARKET PANTR 150-200CT. 16OZ CKD TAIL OFF; UPC: 85239004555 Target item number 210-7-455
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1305-2018·2018-05-09

    Target Recalls Rocky Road Ice Cream Due to Temperature Control Issues

    Target is recalling specific units of MP Ice Cream Rocky Road 48oz purchased in Honolulu, HI, because the shipping container was not held at the proper temperature.

    Product
    MP ICE CREAM ROCKY ROAD 48OZ UPC: 85239734179 Target item number: 288-7-3417
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1210-2018·2018-05-09

    Target Recalls Organic Broccoli Florets Due to Temperature Control Issues

    Target is recalling 2,652 units of Simply Balanced Organic Broccoli Florets sold in Hawaii because a shipping container was not held at the proper temperature.

    Product
    Simply Balanced Organic Broccoli Florets 10oz UPC: 85239008775 Target item number: 270-0-248
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1179-2018·2018-05-09

    Eataly Artichoke Spread Recalled for Undeclared Walnuts

    Eataly NY, LLC is recalling Eataly Artichoke Spread because it contains undeclared walnuts. The product was distributed in New York.

    Product
    eataly artichoke spread, net wt. 7oz 200g, UPC 612067
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0707-2018·2018-05-09

    AuroMedics Recalls Levetiracetam Injection Due to Sterility Concerns

    AuroMedics Pharma LLC is recalling 67,300 bags of Levetiracetam Injection due to a confirmed report of leaking bags and mold found between the outer bag and overwrap.

    Product
    LEVETIRACETAM — LEVETIRACETAM (LEVETIRACETAM IN SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1222-2018·2018-05-09

    Target Recalls Market Pantry Java Chunk Due to Temperature Issues

    Target is recalling Market Pantry Java Chunk 48oz cans sold in Honolulu because a shipping container was not held at the proper temperature, potentially allowing contamination.

    Product
    Market Pantry Java Chunk 48oz UPC: 85239724095 Target item number: 288-7-2409
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1232-2018·2018-05-09

    Target Recalls Canned Corn Due to Temperature Control Issues

    Target is recalling 12-ounce cans of yellow and white corn sold in Hawaii because the shipping container was not held at the proper temperature, potentially allowing contamination.

    Product
    MP CORN 12OZ YELLOW WHITE CORN UPC: 85239005231 Target item number: 270-0-523
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1341-2018·2018-05-09

    Target Recalls 12-Ounce Cauliflower Due to Temperature Control Issues

    Target is recalling 12-ounce cauliflower sold in Hawaii because a shipping container was not held at the proper temperature, which could allow contamination.

    Product
    MP CAULIFLWR 12OZ CAULIFLOWER UPC: 85239521007 Target item number: 270-0-521
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1609-2018·2018-05-09

    Philips MultiDiagnostic-Eleva Imaging System Recalled Due to Uncontrolled Table Rotation

    Philips is recalling the MultiDiagnostic-Eleva imaging system because a broken actuator fixation can cause the patient table to rotate uncontrollably at high speed.

    Product
    MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1258-2018·2018-05-09

    Target Recalls Stouffers Macaroni and Cheese Due to Temperature Issues

    Target is recalling 2,652 units of Stouffers Macaroni and Cheese in Hawaii because a shipping container was not held at the proper temperature, potentially allowing contamination.

    Product
    Stouffers Macaroni and Cheese 12oz UPC: 13800103406 Target item number: 270-2-1499
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1263-2018·2018-05-09

    Target Recalls Organic Cut Corn Due to Temperature Control Issues

    Target is recalling Simply Balanced Organic Cut Corn sold in Hawaii because a shipping container was not held at the proper temperature, potentially allowing contamination.

    Product
    Simply Balanced Organic Cut Corn 10oz. UPC: 85239008713 Target item number: 270-0-578
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0708-2018·2018-05-09

    AuroMedics Recalls Levofloxacin Injection Bags Due to Sterility Concerns

    AuroMedics Pharma LLC is recalling specific lots of Levofloxacin in 5% Dextrose Injection due to a lack of assurance of sterility and reports of leaking bags with mold.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN IN 5% DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1407-2018·2018-05-09

    Parade Salsa Recalled for Potential Glass Contamination

    Giovanni Food Company is recalling Parade Salsa Mild/Suave 24 oz because the product may contain pieces of glass.

    Product
    Parade Salsa MILD/SUAVE NET WT/PESO NETO 24 OZ (1 LB 8 OZ) 680g, UPC: 0 50700 08421 3
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1585-2018·2018-05-09

    Hitachi MHI-TM2000 Linear Accelerator Recalled for Software Anomaly

    Hitachi is recalling one MHI-TM2000 Linear Accelerator System in New York due to a software anomaly that may prevent patient positioning correction, potentially irradiating the wrong body part.

    Product
    MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1608-2018·2018-05-09

    Philips MultiDiagnostic-Eleva Recalled Due to Uncontrolled Table Rotation Hazard

    Philips Medical Systems is recalling 184 MultiDiagnostic-Eleva systems because a broken actuator fixation can cause the table to rotate uncontrollably at high speed.

    Product
    MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1604-2018·2018-05-09

    Philips URODiagnost Imaging System Recalled Due to Uncontrolled Table Rotation

    Philips Medical Systems is recalling 20 URODiagnost imaging systems because the tilt actuator fixation may break, causing the table to rotate uncontrollably at high speed.

    Product
    708033 URODiagnost As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1361-2018·2018-05-09

    Target Recalls Gardein Beefless Ground Due to Temperature Control Failure

    Target is recalling 2,652 units of Gardein Ultimate Beefless Ground in Hawaii because a shipping container was not held at the proper temperature, potentially allowing contamination.

    Product
    Gardein Ultimate Beefless Ground 13.8oz UPC: 842234000988 Target item number: 270-3-9
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1601-2018·2018-05-09

    Southwest Technologies Recalls Hypothermia Mitts, Slippers, and Caps for Misbranding

    Southwest Technologies Inc. is recalling hypothermia mitts, slippers, and caps because they are misbranded for chemotherapy use and linked to two frostbite events.

    Product
    HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), TM7006 (b) Elasto-Gel(TM), TM7006LV (c) Elasto-Gel(TM), TM7007 (d) Elasto-Gel(TM), TM7008 (e) Elasto-Gel(TM), TM7008b (f) Elasto-Gel(TM), TM7009 (g) Elasto-Gel(TM), TM7010…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1356-2018·2018-05-09

    Target Recalls CW Ultimate Southwest Veg Due to Temperature Control Failure

    Target is recalling CW Ultimate Southwest Veg 14oz cans in Hawaii because a shipping container was not held at the proper temperature, posing a risk of contamination.

    Product
    CW ULTIMATE SOUTHWEST VEG 14OZ UPC: 70332002881 Target item number: 270-0-4
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1265-2018·2018-05-09

    Target Recalls MP Fruit Cans Due to Temperature Control Failure

    Target is recalling MP Fruit 48oz cans in Hawaii because a shipping container was not held at the proper temperature, potentially allowing contamination.

    Product
    MP FRUIT 48OZ MEDIUM TRIPLE BRY UPC: 85239270219 Target item number: 270-14-201
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1351-2018·2018-05-09

    Target Recalls Halo Top Caramel Macchiato Ice Cream in Hawaii

    Target is recalling Halo Top Caramel Macchiato Non Dairy Pints in Hawaii because a shipping container was not held at the proper temperature, posing a risk of contamination.

    Product
    Halo Top Caramel Macchiato Non Dairy Pint UPC: 858089003432 Target item number: 288-7-1674
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1602-2018·2018-05-09

    Southwest Technologies Recalls Hypothermia Slippers Due to Misbranding and Frostbite Reports

    Southwest Technologies is recalling hypothermia slippers because they are misbranded for chemotherapy use and two frostbite events were reported.

    Product
    HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), SL3000 (b) Elasto-Gel(TM), SL3000LV (c) Elasto-Gel(TM), SL3001 (d) Elasto-Gel(TM), SL3007 (e) Elasto-Gel(TM), SL3008
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·18V299000·2018-05-07

    Nova Bus Recalls 2015-2017 LFS Models Due to Brake Component Defect

    Nova Bus is recalling 2015-2017 LFS and LFS Artic transit buses because a brake guide pin may break, potentially causing loss of braking ability or tire pressure.

    Product
    NOVA BUS — NOVA BUS LFS, LFS ARTIC
    Category
    Vehicle
    Distribution
    Distributed nationwide