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.

24101–24125 of 32184

  • SevereFDA (Devices)·Z-0921-2015·2015-01-14

    Trumpf Medical Systems Recalls JUPITER U Remote Controls for Unintended Movement

    Trumpf Medical Systems is recalling JUPITER U remote controls because damaged units may cause unintended movement of operating tables during surgery.

    Product
    IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) 102306940. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer…
    Category
    Medical Device
    Distribution
    25 states
  • SevereFDA (Devices)·Z-0881-2015·2015-01-14

    Alere INRatio Monitors Recalled for Potential Inaccurate INR Results

    Alere San Diego, Inc. is recalling INRatio PT/INR Monitor systems because they may provide INR results significantly lower than reference laboratory methods.

    Product
    INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT) Monitoring System - 0100137 Alere INRatio Replacement Monitor The test systems contain individually packaged components needed to use the product, such as a monitor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0334-2015·2015-01-14

    Hospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns

    Hospira Inc. is recalling 30,840 bags of 0.9% Sodium Chloride Injection, USP, 100mL, due to a potential leak at the administrative port that compromises sterility.

    Product
    0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7984-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0882-2015·2015-01-14

    Alere INRatio 2 Monitors Recalled for Potential Inaccurate INR Results

    Alere San Diego, Inc. is recalling INRatio 2 PT/INR monitors because they may provide results significantly lower than reference laboratory methods.

    Product
    INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System - 0200433 Alere INRatio 2 PT/INR Home Monitoring System - 0200457 Alere INRatio 2 Replacement Monitor - 55112 Alere INRatio 2 Replacement…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V010000·2015-01-14

    Winnebago Recalls 2013-2015 Travel Trailers Due to Propane Leak Risk

    Winnebago is recalling specific 2013-2015 Minnie and Sunnybrook Remington travel trailers because the axle may crack the propane pipe fitting, creating a fire hazard.

    Product
    WINNEBAGO — WINNEBAGO, SUNNYBROOK MINNIE, REMINGTON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0908-2015·2015-01-14

    DePuy I.M. Hole Locator Instrument Recalled for Fracture Risk

    DePuy Orthopaedics is recalling 1,130 I.M. Hole Locator Instruments because excessive force during use may lead to intra-operative femoral fracture.

    Product
    I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM Hole preparation. The instrument is positioned between the condyles and aligned with the anatomical axis. Pins can be placed in the IM hole locator to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0931-2015·2015-01-14

    Synthes Small Electric Drive Recalled for Unintended Start and Malfunction

    Synthes (USA) Products LLC is recalling 12 Small Electric Drive units due to potential unintended starts or reverse mode failures that could cause tissue damage.

    Product
    Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand and food applications involving surgical procedures such as drilling, burring, reaming, pin and wire placement, cutting of bone and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0923-2015·2015-01-14

    Trumpf Medical Systems Recalls IIR Remote Controls for Operating Tables

    Trumpf Medical Systems is recalling IIR remote controls for JUPITER operating tables due to reports of unintended movement during surgery.

    Product
    IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 102006720. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer…
    Category
    Medical Device
    Distribution
    25 states
  • SevereFDA (Food)·F-0764-2015·2015-01-14

    Abdallah Caramel Bites Recalled for Peanut Contamination

    Abdallah Candies is recalling Holiday Caramel Bites because a customer found a peanut butter bite in the package.

    Product
    Abdallah Milk Chocolate Bites CARAMEL, Net Wt 4.5 oz. (127g), UPC 7 6668407116 2, Ingredients: Pure milk chocolate (sugar, chocolate liquor, cocoa butter, whole milk, soy lecithin (an emulsifier), vanilla), corn syrup, sweetened condensed milk, cream, sugar, palm oil, salt…
    Category
    Food
    Distribution
    35 states
  • SevereFDA (Devices)·Z-0924-2015·2015-01-14

    Trumpf Medical Systems Recalls JUPITER Remote Controls Due to Unintended Movement

    Trumpf Medical Systems is recalling JUPITER remote controls used with operating tables because complaints were reported of unintended movement during surgical cases.

    Product
    (R)IR remote control JUPITER, Material no.1219656, Serial number: to (incl.) 102317869. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer…
    Category
    Medical Device
    Distribution
    25 states
  • SevereNHTSA·15V012000·2015-01-14

    Nissan and Infiniti Recall Vehicles for Brake Caliper Fastener Issue

    Nissan is recalling 2014-2015 Pathfinder, Rogue, and Infiniti QX60 vehicles because front wheel hub fasteners may be under-torqued, risking brake separation.

    Product
    INFINITI — INFINITI, NISSAN QX60, PATHFINDER, ROGUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·007-2015·2015-01-12

    US Foods Recalls Beef Fajita Strips Due to Undeclared Peanuts

    US Foods is recalling approximately 700 pounds of beef fajita strips because the product contains undeclared peanuts, a known allergen.

    Product
    US Foods Inc — New York Firm Recalls Beef Product Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·006-2015·2015-01-09

    Shirks Meats Recalls Pork Sausage Due to Undeclared Peanut Allergen

    Shirks Meats is recalling approximately 1,062 pounds of smoked pork andouille sausage because it contains undeclared peanuts. No adverse reactions have been reported.

    Product
    Timberline Meats, LLC — New York Firm Recalls Pork Sausage Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·15V006000·2015-01-09

    Ford Recalls 2015 Lincoln MKC Vehicles for Ignition Switch Defect

    Ford is recalling 2015 Lincoln MKC vehicles because the push-to-start button may be pressed accidentally, causing the engine to shut off and increasing crash risk.

    Product
    LINCOLN — LINCOLN MKC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V005000·2015-01-09

    Ford Recalls Vehicles Due to Fuel Pump Failure Risk

    Ford is recalling certain 2014-2015 vehicles because a defective fuel pump may cause the engine to stall without warning, increasing the risk of a crash.

    Product
    FORD — FORD, LINCOLN FOCUS, ESCAPE, FIESTA, EDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·005-2015·2015-01-08

    Yörök Brand Halal Beef Sausage Recalled for Undeclared Peanuts

    The Daniel Weaver Company is recalling approximately 7,092 pounds of Yörök Brand Halal Beef Soujouk products because they contain undeclared peanuts.

    Product
    (Lebanon) - Godshall's Quality Meats, Inc. — Pennsylvania Firm Recalls Beef Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • SevereCPSC·15056·2015-01-08

    CoScentrix Expands Recall of DD Brand Candles Due to Fire Hazard

    CoScentrix is expanding its recall of DD brand candles sold at Hobby Lobby because the high flame can ignite the wax surface, posing a fire hazard.

    Product
    DD brand candles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·15058·2015-01-08

    SKLZ Resistance Trainers Recalled Due to Risk of Severe Injury

    Pro Performance Sports is recalling SKLZ Recoil 360 Resistance Trainers because a weld can break, causing the cord to retract and injure users or partners.

    Product
    SKLZ Recoil 360™ All-Position Resistance Trainers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·004-2015·2015-01-08

    Unibright Recalls Beef and Pork Products Due to Metal Contamination

    Unibright Foods is recalling frozen sukiyaki beef and gingered pork products that may contain metal extraneous materials. No injuries or illnesses have been reported.

    Product
    Unibright Foods, Inc. — California Firm Recalls Beef and Pork Products Due to Foreign Matter Contamination
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0328-2015·2015-01-07

    Tropichem Recalls Entertainer's Secret Throat Relief Due to E. Coli Contamination

    Tropichem Research Labs is recalling Entertainer's Secret Throat Relief due to microbial contamination, including E. Coli. The product was distributed in New York and Indiana.

    Product
    Entertainer's Secret Throat Relief, 2.0 FL oz (59.2 mL), Honey Apple Flavor, KLI Corp, Carmel, IN
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0329-2015·2015-01-07

    Ginseng Kianpi Pill Recalled for Undeclared FDA-Approved Drugs

    One and Zen is recalling Ginseng Kianpi Pill capsules because FDA analysis found undeclared dexamethasone and cyproheptadine, making the product an unapproved drug.

    Product
    GINSENG KIANPI PIL, 60 capsules, PRODUCT OF KWEILIN DRUG MANUFACTORY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0889-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender II Infusion Sets Due to Tubing Detachment

    Roche Diagnostics is recalling ACCU-CHEK Tender II infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender II 13/60 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0896-2015·2015-01-07

    Hansen Medical Recalls Sensei X Robotic Catheter Systems Due to Loose Clamp

    Hansen Medical is recalling Sensei X Robotic Catheter Systems because a mechanical clamp may become loose, causing the device to fall and potentially injure patients or users.

    Product
    Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table. Product Usage: The Sensei X Robotic Catheter System is an electromechanical software controlled system designed to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0760-2015·2015-01-07

    Regency Group Recalls Organic Cilantro Due to Salmonella Risk

    The Regency Group is recalling Organic Cilantro Cut & Sifted due to potential Salmonella contamination. The product was distributed in Oregon and Washington.

    Product
    Organic Cilantro Cut & Sifted, packaged in 1 lb. or 20 lbs. The product is labeled in parts: "***Organic Cilantro Cut & Sifted***OREGON SPICE COMPANY***13320 NE Jarrett St. Portland, Oregon 97230***".
    Category
    Food
    Distribution
    2 states