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.

28501–28525 of 32252

  • SevereFDA (Drugs)·D-249-2013·2013-04-24

    Teva Recalls Copaxone Syringes Due to Visible Silicone Oil Presence

    Teva Pharmaceuticals is recalling 6,692 boxes of Copaxone (glatiramer acetate) injection due to visible medical grade silicone oil in the syringes.

    Product
    COPAXONE — COPAXONE (GLATIRAMER ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1074-2013·2013-04-24

    Lifescan Recalls OneTouch Verio IQ Blood Glucose Meters for Display Error

    Lifescan is recalling OneTouch Verio IQ Blood Glucose Meters because they shut off instead of displaying 'EXTREME HIGH GLUCOSE' at high readings.

    Product
    All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits - Meter; Verio IQ Warranty Meter. Product Usage: The OneTouch¿ VerioIQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1117-2013·2013-04-24

    Hospira GemStar Infusion Pump Recall for Potential Over-Infusion

    Hospira is recalling GemStar infusion pumps because the motor may rotate backwards during low-rate infusions, causing the device to deliver too much medication.

    Product
    The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1323-2013·2013-04-24

    La Preferida Pinto Beans Recalled for Potential Pathogen Contamination

    La Preferida Inc is recalling 57,040 cans of pinto beans because some may not have been fully processed, posing a risk of illness from spoilage organisms or pathogens.

    Product
    Metal cans; labeled as containing 29 oz of pinto beans packed in water and salt
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1051-2013·2013-04-17

    GE Healthcare Recalls Giraffe OmniBed and Incubator Units for Display Errors

    GE Healthcare is recalling 679 Giraffe OmniBed and Incubator units because display boards may randomly overwrite stored information and set points upon power up or recovery from a power failure.

    Product
    Giraffe OmniBed¿ and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer.
    Category
    Medical Device
    Distribution
    29 states
  • SevereFDA (Devices)·Z-1063-2013·2013-04-17

    FDA Recalls Covidien Endo GIA AutoSuture Universal Loading Units

    FDA is recalling 6,751 units of the Covidien Endo GIA AutoSuture Universal Loading Unit because a defect may cause difficulty firing the device, potentially requiring medical intervention.

    Product
    Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1312-2013·2013-04-17

    Sage Creek Recalls Canned Peaches Due to Underprocessing and Swollen Cans

    Sage Creek Inc is recalling Hood-Crest canned peaches in the Western US due to reports of underprocessed fruit and swollen or bursting cans.

    Product
    Canned Peach Slices in Light Syrup or canned Peach Slices in Heavy Syrup or canned Peach halves in Heavy Syrup. The PDP reads "HOOD-CREST ELBERTA PEACHES YELLOW FREESTONE SLICES IN LIGHT SYRUP NET WT. 28 OZ. (1LB. 12 OZ.) 793G" The back panel reads in part "***INGREDIENTS…
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1066-2013·2013-04-17

    Stelkast Cross-over Acetabular Shell and Liner Hip System Recalled

    Stelkast Co is recalling 254 units of the Cross-over Acetabular Shell and Liner Hip System due to difficulty engaging and securing the liner.

    Product
    Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1300-2013·2013-04-17

    Nutrex Research Recalls Lipo 6 Black Ultra Concentrate Due to DMAA

    Nutrex Research is recalling Lipo 6 Black Ultra concentrate Fat Destroyer because samples contain DMAA (Methylhexanamine). The recall affects 82,417 sample packets distributed in eight states.

    Product
    Nutrex Research Lipo 6 Black Ultra concentrate Fat Destroyer
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-1301-2013·2013-04-17

    Sunchang Ssamjang Sesame and Garlic Bean Paste Recalled for Peanut Mislabeling

    Daesang America is recalling Sunchang Ssamjang bean paste because the English label omits peanut powder, a major allergen listed in Korean.

    Product
    Sunchang Ssamjang Sesame and Garlic Seasoned Bean Paste 500 g - Net Wt. 17.64 oz., UPC Code 880152435671 Distributed by: Daesang America, Inc. Hackensack, NJ 07601 TEL: (201) 488-4010 Product of Korea
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1081-2013·2013-04-17

    Siemens ACUSON SC2000 Ultrasound System Recalled for Temperature Display Error

    Siemens is recalling ACUSON SC2000 ultrasound systems with specific hardware due to a temperature display error that may underestimate transducer heat, posing a burn risk.

    Product
    Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1314-2013·2013-04-17

    Sage Creek Recalls Canned Apricots Due to Underprocessing and Swollen Cans

    Sage Creek Inc is recalling Hood-Crest canned apricots in light or heavy syrup due to reports of underprocessing, swollen cans, and undercooked fruit.

    Product
    Canned Apricot in Light Syrup or canned Apricot in Heavy Syrup. The PDP reads "HOOD-CREST APRICOTS UNPEELED HALVES IN LIGHT SYRUP NET WT. 28 OZ. (1LB. 12 OZ.) 793G". The back panel reads in part "*** INGREDIENTS: APRICOTS, WATER, SUGAR. MUIRHEAD CANNING CO. The Dalles…
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·13V145000·2013-04-17

    E-One Recalls Cyclone II Fire Trucks Due to Brake Fire Risk

    E-One is recalling 2011-2013 Cyclone II fire fighting vehicles because brake chambers may leak, causing brakes to drag and overheat, which could lead to a fire.

    Product
    E-ONE — E-ONE CYCLONE II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1058-2013·2013-04-17

    Respironics Infant Masks Recalled Due to Incorrect Size Labeling

    Engineered Medical Systems is recalling Respironics SealFlex Single Port Ribbed Masks labeled as Infant but actually Neonatal size.

    Product
    Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .
    Category
    Medical Device
    Distribution
    5 states
  • SevereNHTSA·13V147000·2013-04-17

    Explorer Van Company Recalls 2013 GMC Savana and Chevrolet Express Vans

    Explorer Van Company is recalling 885 model year 2013 Explorer and Explorer Limited SE vans built on GMC Savana and Chevrolet Express chassis due to a wiring harness defect that may cause a fire.

    Product
    GMC — GMC, CHEVROLET SAVANA, EXPRESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1302-2013·2013-04-17

    Green Day White Melon Seeds Recalled for Undeclared Sulfites

    Domega NY International Co Ltd is recalling Green Day brand White Melon Seeds due to undeclared sulfites detected by New York State authorities.

    Product
    GREEN DAY brand White Melon Seeds, Net Wt. 9.8 oz (280g) , UPC 6 868978 724120, Produce of P.R.C. --- Firms on Label: Manufacturer: Jiangmen Xinhui Parksun Food Co., Ltd. Add: Donggua Hill, Beltou Village, Qibao, Xinhui District, Jiangmen City, Guangdong -- Packed For…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1078-2013·2013-04-17

    GE Healthcare Recalls Infinia Nuclear Medicine Systems Due to Mechanical Failure Risk

    GE Healthcare is recalling Infinia Nuclear Medicine Systems because a mechanical defect could cause the detector to slide, posing a risk to patients and operators.

    Product
    GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, all configurations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1313-2013·2013-04-17

    Sage Creek Recalls Canned Bartlett Pear Halves Due to Processing Defects

    Sage Creek Inc is recalling canned Bartlett pear halves in light or heavy syrup due to reports of under-processed fruit and swollen or bursting cans.

    Product
    Canned Pear Halves in Light Syrup or canned Pear Halves in Heavy Syrup. The PDP reads "HOOD-CREST HALVES BARTLETT PEARS IN HEAVY SYRUP NET WT. 28 OZ. (1 LB. 12 OZ.) 793G" and the back panel reads in part "***INGREDIENTS: PEARS WATER, SUGAR. Packed by MUIRHEAD CANNING CO. The…
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1299-2013·2013-04-17

    NewChapter Probiotic Elderberry Recalled for Undeclared Soy Allergen

    New Chapter, Inc. is recalling 1,004 bottles of Probiotic Elderberry dietary supplements because they may contain undeclared soy.

    Product
    NewChapter Probiotic Elderberry, 90 vegetarian capsules bottle. Dietary Supplement UPC: 7-27783-00123-8
    Category
    Food
    Distribution
    38 states
  • SevereNHTSA·13V142000·2013-04-16

    MCI Motorcoaches Recalled for Exhaust System Fire Risk

    Motor Coach Industries is recalling 2012-2013 MCI motorcoaches because an incorrectly assembled exhaust bellows pipe could fail, allowing hot gases to escape and cause a fire.

    Product
    MCI — MCI D4000, D4505, D4500, D4000ISTV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V140000·2013-04-15

    Seagrave Recalls Marauder II Pumper Vehicles Due to Brake Fire Risk

    Seagrave is recalling 2011-2012 Marauder II pumper emergency vehicles because brake chambers may leak, causing the parking brake to drag and potentially leading to a fire.

    Product
    SEAGRAVE — SEAGRAVE MARAUDER II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V139000·2013-04-12

    Nissan Recalls 2013 Pathfinder and Infiniti JX for Brake Defect

    Nissan is recalling 2013 Pathfinder and Infiniti JX vehicles due to a structural weakness in the front brake torque member that could lead to reduced braking.

    Product
    NISSAN — NISSAN, INFINITI PATHFINDER, JX
    Category
    Vehicle
    Distribution
    Distributed nationwide