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.

20376–20400 of 32118

  • SevereFDA (Devices)·Z-1422-2016·2016-04-20

    Customed Plastic Surgery Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 15 units of Plastic Surgery Packs (Catalog Number 9001402) distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001402 PLASTIC SURGERY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-1034-2016·2016-04-20

    JRZ Dairy Products Recalls Yogurt for Pasteurization Failure

    JRZ Dairy Products Inc. is recalling three brands of whole milk yogurt because the products were not pasteurized for the required length of time.

    Product
    Puredesi Whole Milk Yogurt in 5 lb. plastic containers Patidar Whole Milk Yogurt in 5 lb. plastic containers Puredahi Whole Milk Yogurt in 5 lb. plastic containers Sell by: 5/08/2016
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1334-2016·2016-04-20

    Dexcom G4 Platinum Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling G4 PLATINUM Receivers because they may fail to provide intended audible alarms or alerts to users.

    Product
    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1046-2016·2016-04-20

    Kroger Chicken Salad Croissant Sandwiches Recalled for Undeclared Fish

    Mt Perry Foods is recalling Kroger Brand Chicken Salad Croissant Sandwiches sold in Ohio and West Virginia because they contain undeclared fish.

    Product
    Kroger Brand Chicken Salad Croissant Sandwiches packaged in individual clear rigid plastic clamshell containers packaged in 6 brown corrugated card board boxes, 6 to a case, for a total of 36 sandwiches. Cases identified with white stick on label with black ink printing reading…
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1026-2016·2016-04-20

    Gold Medal Cincinnati Style Chili Recalled for Undeclared Milk

    Gold Medal Products is recalling 4 lb jars of Cincinnati Style Chili because the label failed to declare milk as an ingredient.

    Product
    #2473 CINCINNATI STYLE CHILI Savory Net Wt. 4 lbs (1.8kg) UPC 0 90939 12473 1 GOLD MEDAL PRODUCTS 10700 MEDALLION DRIVE CINCINNATI, OHIO 45241
    Category
    Food
    Distribution
    16 states
  • SevereFDA (Devices)·Z-1393-2016·2016-04-20

    RTI Surgical Streamline OCT Final Driver Recalled for Fracture Risk

    RTI Surgical is recalling Streamline OCT Final Drivers due to reduced mechanical strength that may cause the tip to fracture during use.

    Product
    RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Food)·F-1047-2016·2016-04-20

    Figi's Classic Marzipan Recalled for Unlabeled Almond Content

    Figi's is recalling 8-ounce packages of Classic Marzipan because the product contains almonds that are not properly labeled on the ingredients list.

    Product
    Figi's Classic Marzipan, item 100-0034-200, 8 ounce
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1336-2016·2016-04-20

    Dexcom G4 PLATINUM Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling G4 PLATINUM receivers because they may fail to provide intended audible alarms or alerts for diabetes patients.

    Product
    Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect trends and track glucose patterns in persons with diabetes. The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1338-2016·2016-04-20

    Dexcom G4 Platinum Pediatric Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling 19,586 G4 Platinum Pediatric Receivers because they may fail to provide intended audible alarms or alerts.

    Product
    Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V226000·2016-04-20

    StarTrans Senator II Transit Buses Recalled for Seat Separation Risk

    Forest River is recalling 2016 StarTrans Senator II transit buses because seats may separate from the base frame due to bolt failure, increasing injury risk in a crash.

    Product
    STARTRANS — STARTRANS SENATOR II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V227000·2016-04-20

    Starcraft Bus Recalls 2015-2016 Prodigy and Quest School Buses

    Forest River is recalling 2015-2016 Starcraft Prodigy and Quest school buses because seats may separate from the base frame due to bolt failure.

    Product
    STARCRAFT BUS — STARCRAFT BUS QUEST, PRODIGY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·16148·2016-04-19

    Brunton Recalls Rechargeable Battery Packs Due to Fire Hazard

    Brunton Outdoor Inc. is recalling Impel and Impel 2 rechargeable battery packs because they can overheat and catch fire during charging.

    Product
    Rechargeable battery packs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V225000·2016-04-19

    Forest River Recalls 2016 Glaval Buses Due to Seat Separation Risk

    Forest River is recalling 2016 Glaval Entourage and Universal buses because seats may separate from the base frame due to bolt failure, increasing injury risk in a crash.

    Product
    GLAVAL BUS — GLAVAL BUS ENTOURAGE, UNIVERSAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·030-2016·2016-04-16

    AdvancePierre Recalls Breaded Pork Patties for Undeclared Egg Allergen

    AdvancePierre Foods is recalling approximately 3,469 pounds of breaded pork patties because they contain eggs, a known allergen, that are not declared on the label.

    Product
    AdvancePierre Foods, Inc. — Advancepierre Foods Recalls Pork Products Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    4 states
  • SevereNHTSA·16V215000·2016-04-14

    Toyota Recalls 2016 Camry and Avalon for Air Bag Calibration Issues

    Toyota is recalling 58,515 model year 2016 Camry and Avalon vehicles because the occupant classification system may be improperly calibrated, potentially preventing front passenger air bags from deploying.

    Product
    TOYOTA — TOYOTA CAMRY, AVALON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0803-2016·2016-04-13

    Meditech Formula 4 Injection Recalled for Sterility Assurance Issues

    Meditech Laboratories is recalling Formula 4 Injection vials due to incomplete data regarding production sterility.

    Product
    Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/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-0808-2016·2016-04-13

    Meditech Formula 2 Vials Recalled Due to Expired Active Ingredient

    Meditech Laboratories is recalling Formula 2 vials because an active ingredient expired before the labeled Beyond Use Date.

    Product
    Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1039-2016·2016-04-13

    NutraKey Recalls VPro Raw Plant Protein Due to Undeclared Soy

    NutraKey, Inc. is recalling VPro Raw Plant Protein, Chocolate, because it contains undeclared soy. The recall covers 17,730 units distributed nationwide.

    Product
    VPro Raw Plant Protein, Chocolate. 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 (Food)·F-1002-2016·2016-04-13

    Whole Foods Market Recalls Maytag Blue Cheese for Listeria Risk

    Whole Foods Market is recalling Maytag Blue Cheese products due to possible contamination with Listeria monocytogenes.

    Product
    Whole Foods Market Maytag Blue Cheese, Maytag Blue Raw Milk, Maytag Iowa Blue Cheese cut and wrapped in clear plastic wrap, Dist. by Whole Foods Market 550 Bowie Street Austin, TX 78703, PLU: 0293308
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0816-2016·2016-04-13

    Actavis Recalls Amphetamine Tablets Due to Impurity Failures

    Actavis is recalling specific lots of amphetamine tablets because they failed impurity specifications. Consumers should stop using the product and contact their pharmacist.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 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-1272-2016·2016-04-13

    Focus Diagnostics Recalls Simplexa HSV 1&2 Direct Amplification Discs

    Focus Diagnostics is recalling Simplexa HSV 1&2 Direct Amplification Discs because they may cause false negative or positive results and error codes.

    Product
    Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1012-2016·2016-04-13

    Loki Fish Company Recalls Wild Smoked Pink Salmon for Listeria

    Loki Fish Company is recalling Wild Smoked Pink Salmon portions due to a positive test result for Listeria monocytogenes. The product was distributed in Oregon and Washington and sold via mail order to Florida, Georgia, and Ohio.

    Product
    Wild Smoked Pink Salmon, 4-7 ounce portions in clear plastic package. No UPC. Label is read in parts: "***Smoked PINK SALMON***KEEP REFRIGERATED BELOW 38F***LOKI FISH CO***SEATTLE-WA***".
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1040-2016·2016-04-13

    NutraKey Recalls VPro Raw Plant Protein for Undeclared Soy

    NutraKey, Inc. is voluntarily recalling VPro Raw Plant Protein, Vanilla, due to undeclared soy. The product was distributed nationwide.

    Product
    VPro Raw Plant Protein, Vanilla. 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