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.

20401–20425 of 32118

  • SevereFDA (Devices)·Z-1274-2016·2016-04-13

    Focus Diagnostics Recalls Simplexa Group A Strep Direct Amplification Discs

    Focus Diagnostics is recalling Simplexa Group A Strep Direct Amplification Discs because they may cause false test results or error codes.

    Product
    Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1327-2016·2016-04-13

    Synthes Recalls Titanium Low Profile Neuro Screws Due to Thread Defect

    Synthes (USA) Products LLC is recalling specific lots of Titanium Low Profile Neuro Screws because the thread height is undersized, potentially compromising the device's structural integrity.

    Product
    Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1032-2016·2016-04-13

    Sweetwater Sprouted Clover Recalled for Potential Salmonella Contamination

    Sweetwater Farms LLC is recalling specific lots of 100% Pure Sprouted Clover due to potential Salmonella contamination. The product was distributed in Arkansas, Kansas, and Oklahoma.

    Product
    Sweetwater Sprouts100% Pure Sprouted Clover packaged in plastic bags and shipped in cardboard cases labeled with product, Net Wt. 5 lb. and lot number. The responsible name on the label is Sweetwater Farms, Inman, KS 67546.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1024-2016·2016-04-13

    Bay Valley Foods Recalls Crispers Honey Lime Dressing for Undeclared Egg

    Bay Valley Foods is recalling Crispers Honey Lime Dressing because it contains egg, an undeclared allergen. The product was distributed in Florida.

    Product
    Crispers Honey Lime Dressing, 1 GL, Distributed by Bay Valley Foods, LLC, Oak Brook, IL 60523
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·16V211000·2016-04-13

    Mercedes-Benz Recalls 2016 SLK300 Vehicles Due to Ignition Wiring Defect

    Mercedes-Benz is recalling 2016 SLK300 vehicles because a backup power supply for the ignition switch may not be properly connected, creating a risk of the vehicle rolling.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SLK300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V213000·2016-04-13

    Karavan Recalls 2016 KPSD Trailers Due to Axle Spindle Flange Defect

    Karavan is recalling 2016 KPSD trailers because a defective axle spindle flange may bend, causing excessive tire wear and increasing the risk of tire failure and a crash.

    Product
    KARAVAN — KARAVAN KPSD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1038-2016·2016-04-13

    NutraKey Recalls VPro Raw Plant Protein for Undeclared Soy

    NutraKey, Inc. is voluntarily recalling VPro Raw Plant Protein nationwide due to undeclared soy, a major food allergen.

    Product
    VPro Raw Plant Protein, Natural. Packaged in a plastic bottle with green, white, and black adhesive label. Packaged in 2 lb (30 serving).
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0926-2016·2016-04-13

    BJ's Wholesale Club Recalls Cittero Mortadella Due to Undeclared Pistachios

    BJ's Wholesale Club is recalling Cittero Mortadella because it contains undeclared pistachios. The product was sold at 71 locations in eight states.

    Product
    Cittero Mortadella, packaged in deli bags. This is a deli service item.
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Drugs)·D-0814-2016·2016-04-13

    Actavis Recalls Dextroamphetamine Tablets Due to Impurity Failures

    Actavis Elizabeth LLC is recalling 257,746 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, because they failed impurity specifications.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1323-2016·2016-04-13

    MicroAire French Rasp Aspiration Cannula Recalled for Bending or Breaking

    MicroAire Surgical Instruments is recalling 37 units of the PAL-R4011XL French Rasp aspiration cannula because they bent or broke during surgery.

    Product
    MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1315-2016·2016-04-13

    ScottCare TeleSentry Battery Recall Due to Explosion Risk During Recharging

    ScottCare is recalling 9,067 TeleSentry batteries after a complaint that one exploded while recharging. The batteries are used in cardiac monitoring devices.

    Product
    TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature. Do not disassemble. Dispose of properly. Use specified charger only. 60pC/140pF The ScottCare Corporation. Intended for diagnostic evaluation of patients who experience transient…
    Category
    Medical Device
    Distribution
    24 states
  • SevereFDA (Drugs)·D-0804-2016·2016-04-13

    Meditech Formula 9 Injection Recalled for Sterility Assurance Issues

    Meditech Laboratories is recalling Formula 9 Injection vials due to incomplete production data regarding sterility assurance.

    Product
    Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1037-2016·2016-04-13

    NutraKey Recalls VPro Raw Plant Protein Due to Undeclared Soy

    NutraKey, Inc. is recalling VPro Raw Plant Protein, Mocaccino, because it contains undeclared soy. The product was distributed nationwide.

    Product
    VPro Raw Plant Protein, Mocaccino. Packaged in a plastic bottle with green, white, and black adhesive label. Packaged in 1 lb (15 serving) and 2 lb (30 serving).
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0807-2016·2016-04-13

    Meditech Formula 0 Injection Recalled for Sterility Assurance Issues

    Meditech Laboratories is recalling Formula 0 Injection due to incomplete production data regarding sterility assurance.

    Product
    Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0802-2016·2016-04-13

    Meditech Formula 2 Injection Recalled for Superpotent Drug Ingredient

    Meditech Laboratories is recalling Formula 2 Injection vials because one ingredient exceeded assay specifications, making the drug superpotent.

    Product
    Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1031-2016·2016-04-13

    Sweetwater Sprouts Recalled for Potential Salmonella Contamination

    Sweetwater Farms LLC is recalling sprouted alfalfa due to potential Salmonella contamination. The product was distributed in Arkansas, Kansas, and Oklahoma.

    Product
    Sweetwater Sprouts 100% Pure Sprouted Alfalfa packaged in the following configurations: 4 oz. plastic bags (UPC 7 56733 00104 2) packed 12 per case; 16 oz. (1 lb.) plastic bags; and 5 lb. bulk boxes The product is shipped in cardboard cases labeled with product and lot…
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·16V214000·2016-04-13

    Hillsboro Aluminum Utility Trailer Recall for Axle Hardware Defect

    Hillsboro is recalling 2016 aluminum utility trailers because improperly installed axle hardware may cause the axle to shift, increasing crash risk.

    Product
    HILLSBORO — HILLSBORO ALUMINUM UTILITY TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V206000·2016-04-12

    Freightliner Trucks Recalled for Rear Brake Caliper Installation Error

    Daimler Trucks North America is recalling 2010-2017 Freightliner trucks because incorrectly installed rear brake calipers may contact the suspension, reducing braking effectiveness.

    Product
    FREIGHTLINER — FREIGHTLINER 108SD, COLUMBIA, BUSINESS CLASS M2, 114SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·028-2016·2016-04-12

    Mountain Products Recalls Pork Products Due to Undeclared Allergens

    Mountain Products Inc. is recalling approximately 467 pounds of bacon and pork sausage products because they contain undeclared milk, soy, and wheat allergens.

    Product
    Mountain Products Inc. — Mountain Products Inc. Recalls Pork Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • SevereCPSC·16140·2016-04-12

    Coleman Recalls CTAC Lithium-Ion Flashlights Due to Fire Hazard

    Coleman is recalling about 8,500 CTAC lithium-ion flashlights sold in the U.S. because the batteries can overheat and catch fire.

    Product
    Coleman® CTAC Lithium-Ion Flashlights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V203000·2016-04-11

    Mazda Recalls CX-3, Mazda2, CX-5, and CX-9 for Steering Knuckle Defect

    Mazda is recalling specific 2013-2016 CX-3, Mazda2, CX-5, and CX-9 vehicles because front strut mounting bolts may loosen, potentially causing a loss of steering control.

    Product
    MAZDA — MAZDA CX-9, MAZDA2, CX-5, CX-3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V202000·2016-04-11

    Ram ProMaster City Recall for Electrical Harness Water Intrusion

    Chrysler is recalling 2015-2016 Ram ProMaster City vans because a low-voltage electrical harness connector may corrode, causing the transmission to unexpectedly shift into neutral.

    Product
    RAM — RAM PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide