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.

28876–28900 of 32253

  • SevereNHTSA·13V001000·2013-01-02

    GM Recalls 2013 Trucks and SUVs for Transmission Shift Defect

    General Motors is recalling 54,686 model year 2013 vehicles due to a transmission defect that may allow the vehicle to roll away.

    Product
    CHEVROLET — CHEVROLET, GMC, CADILLAC SILVERADO, AVALANCHE 1500, SIERRA, EXPRESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-100-2013·2013-01-02

    Lloyd Inc. Recalls Subpotent Thyro-Tab 0.050 mg. Tablets

    Lloyd Inc. of Iowa is recalling specific lots of Thyro-Tab 0.050 mg. tablets because they are subpotent and have a 9-month stability interval.

    Product
    Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0594-2013·2013-01-02

    Zimmer Spine Ardis Inserter Recalled for Potential Spacer Fragmentation

    Zimmer, Inc. is recalling the Spine Ardis Inserter because excessive force can break the PEEK spacer, causing sharp fragments that may damage adjacent structures.

    Product
    Zimmer Spine Ardis Inserter, Rx, non-sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0606-2013·2013-01-02

    GE T-Piece Resuscitation Circuits Recalled for Pressure Deficiency

    GE Healthcare is recalling T-Piece Neonatal Patient Circuit Kits because they cannot achieve maximum Peak Inspiratory Pressure during pre-use checks.

    Product
    GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable…
    Category
    Medical Device
    Distribution
    47 states
  • SevereFDA (Drugs)·D-104-2013·2013-01-02

    Alara Recalls Subpotent Levothyroxine Sodium Tablets Due to Stability Issues

    Alara Pharmaceutical is recalling 7,432 bottles of Levothyroxine Sodium Tablets because the product is subpotent and has stability issues.

    Product
    Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereCPSC·13085·2013-01-02

    Brower Recalls Top Hatch Egg Incubators Due to Fire Hazard

    Brower is recalling about 2,500 Top Hatch egg incubators because the base can ignite during use, posing a fire hazard. Three fires with property damage have been reported.

    Product
    Egg Incubator
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0852-2013·2013-01-02

    Golub Cinnamon Coffee Cake Recalled for Missing Walnut Allergen Labeling

    Golub Corp is recalling CMC Cinnamon Coffee Cakes incorrectly labeled as Pumpkin Coffee Cake, which failed to list walnuts as an ingredient.

    Product
    CMC Pumpkin Coffee Cake 16 oz UPC: 041735225726 Price Chopper/Box
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0853-2013·2013-01-02

    Spence & Co Nova Lox and Smoked Salmon Trimmings Recalled for Listeria

    Spence & Co. is recalling refrigerated Nova Lox and Smoked Salmon Trimmings due to Listeria monocytogenes contamination. Consumers should discard or return these products.

    Product
    Spence & Co New York-Style Nova Lox 4oz , refrigerated Spence & Co Smoked Salmon Trimmings, 2lb bulk (bag)
    Category
    Food
    Distribution
    22 states
  • SevereFDA (Drugs)·D-105-2013·2013-01-02

    Roche Recalls Cymevene Powder for Infusion Due to Sterility Concerns

    F. Hoffmann-LaRoche Ltd. is recalling Cymevene 500 mg Powder for Infusion due to container closure issues that compromise sterility assurance. No product was distributed in the USA.

    Product
    Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, Welwyn Garden City, AL7 1TW, United Kingdom
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-0854-2013·2013-01-02

    Taylor Farms Hearts of Romaine Lettuce Recalled for Listeria Monocytogenes

    Taylor Farms is recalling specific bags of Hearts of Romaine Lettuce after a positive sample of Listeria Monocytogenes was found.

    Product
    Taylor Farms Hearts of Romaine Lettuce, All Natural, Fresh Hand Selected, Triple Washed and Ready to Enjoy. 10 oz. bags. Taylor Farms, Salinas, CA. UPC 0 30223 04032 3
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-101-2013·2013-01-02

    Lloyd Inc. of Iowa Recalls Subpotent Levothroid Levothyroxine Sodium Tablets

    Lloyd Inc. of Iowa is recalling specific lots of Levothroid (levothyroxine sodium) tablets because they are subpotent and have a 9-month stability interval.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·12E057000·2012-12-28

    Neotek Recalls DURALAST Brake Rotors Due to Fracture Risk

    Neotek is recalling DURALAST brake rotors sold at Autozone because a narrow casting area may fracture, reducing braking performance and increasing crash risk.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0548-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Broach and Associated Tools

    Zimmer, Inc. is recalling 92 units of Persona Knee System Tibial Broaches and associated tools due to a risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Broach, Cemented, Size E-F, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0574-2013·2012-12-26

    DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk

    DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because an engineering analysis found they may impinge with certain heads, preventing them from locking as intended.

    Product
    SOL SYS F 8 CALC 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0542-2013·2012-12-26

    Zimmer Recalls Persona Knee Implants to Reduce Tibial Perforation Risk

    Zimmer, Inc. is recalling Persona knee implants and associated tools to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE F, LEFT TIBIA SIZE F RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0553-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Sizing Plates

    Zimmer, Inc. is recalling 188 Persona Tibial Sizing Plates due to a risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size F Left; Size F Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0554-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Sizing Plates

    Zimmer, Inc. is recalling 189 Persona Knee System Tibial Sizing Plates to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size G Left; Size G Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0539-2013·2012-12-26

    Zimmer Recalls Persona Knee Implants to Reduce Tibial Perforation Risk

    Zimmer, Inc. is recalling 318 units of Persona Knee System tibial implants and tools to reduce the risk of tibial perforation and fracture.

    Product
    Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile SIZE C, LEFT; SIZE C RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0550-2013·2012-12-26

    Zimmer Persona Tibial Sizing Plate Recalled for Perforation Risk

    Zimmer, Inc. is recalling Persona Tibial Sizing Plates and related tools to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size C Left; Size C Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0552-2013·2012-12-26

    Zimmer Persona Knee System Tibial Sizing Plates Recalled for Perforation Risk

    Zimmer, Inc. is recalling 188 Persona Tibial Sizing Plates to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size E Left; Size E Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0546-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Drill Guide

    Zimmer, Inc. is recalling 94 units of the Persona Tibial Drill Guide to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 mm Diameter, Nonsterile, Nonsterile This drill guide is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic…
    Category
    Medical Device
    Distribution
    Distributed nationwide