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.

27801–27825 of 32242

  • SevereFDA (Devices)·Z-1768-2013·2013-07-31

    LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Bleeding

    LeMaitre Vascular is recalling AlboGraft Woven with Collagen grafts due to blood leaking from the graft surface after implantation.

    Product
    AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-1718-2013·2013-07-24

    Kroger Recalls QFC Chicken Pesto Panini for Allergen Mislabeling

    Kroger is recalling QFC Chicken Pesto Paninis in Washington and Oregon because they may contain undeclared soy and egg allergens.

    Product
    QFC Chicken Pesto Panini wrapped in polywrap packaging, 10.32 oz. in size, included with five (5) other types of sandwiches in a 6-count "variety pack" case.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1738-2013·2013-07-24

    St. Jude Medical Recalls Eon Spinal Cord Stimulator Charging Systems

    St. Jude Medical is recalling Eon and Eon Mini charging systems due to reports of skin burns and discomfort at the implant site during use.

    Product
    Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1719-2013·2013-07-24

    Nassau Candy Recalls Pistachios for Potential Salmonella Contamination

    Nassau Candy is recalling 6.25 lb packages of in-shell pistachios due to potential Salmonella contamination. The product was distributed across 13 states.

    Product
    PISTACHIOS-INSHELL-R/S-21/25-6.25LB, Net Wt. 6.25 LB. Item number: 920. Product is packed in a clear plastic liner then in a white corrugated bag. Distributed by Nassau Candy 530 West John Street Hicksville, NY 11801.
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Food)·F-1724-2013·2013-07-24

    Sani Fresh Mini Kaiser Rolls Recalled for Undeclared Soy and Wheat

    Sani Fresh Distribution is recalling Mini Kaiser 10 rolls due to undeclared soy, wheat, sulfites, and gluten. The product was distributed in Queens, NY.

    Product
    Sani Fresh Distribution brand MINI KAISER 10, Net Weight 13 OZ, Product of Canada, UPC 0 56931 51125 2 --- DISTRIBUTED BY SANI BAKERY INC. 28-24 STEINWAY ST., SUITE 108, ASTORIA NY 11103 --- The mini kaisers are packed in clear plastic sealed bags (contain 10 rolls per bag)…
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-799-2013·2013-07-24

    Arm & Hammer Sodium Bicarbonate Powder Recalled for Contamination

    Church & Dwight is recalling Arm & Hammer Sodium Bicarbonate Powder due to the presence of stainless steel and other foreign substances.

    Product
    Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 3 Fine Powdered, Net Wt. 50 lbs. (22.68 kg.) per…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1722-2013·2013-07-24

    MR Cuts Recalls Sliced Mango Products Due to Salmonella Risk

    MR Cuts, L.p. is recalling sliced mango products sourced from Agricola Daniella due to potential Salmonella contamination. The products were distributed in Texas.

    Product
    Item # H175455 Mango Sliced 2/2.5 LB and 5 LB, Ingredients: Mango Packed By: Riley's Dallas, Texas 75226 Product of Mexico
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1753-2013·2013-07-24

    Liebel-Flarsheim Hydra Vision DR 60/80 System Recalled for High Dosage

    Liebel-Flarsheim is recalling 12 Hydra Vision DR 60/80 systems because a service call found the maximum fluoroscopy dose was three times the safety limit.

    Product
    Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V324000·2013-07-24

    Nissan Recalls 2014 Versa Note Vehicles for Body Sill Bolt Defect

    Nissan is recalling 2014 Versa Note vehicles because lower body sill bolts may be missing or incorrectly torqued, which could affect vehicle integrity in a rear impact.

    Product
    NISSAN — NISSAN VERSA NOTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V323000·2013-07-24

    Moto Guzzi Recalls 2012-2013 Models for Rear Suspension Defect

    Piaggio is recalling 680 Moto Guzzi motorcycles because rear suspension links could fracture, increasing the risk of a crash.

    Product
    MOTO GUZZI — MOTO GUZZI NORGE 1200, STELVIO NTX 1200, GRISO 1200
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1721-2013·2013-07-24

    MR Cuts Recalls Diced Mango Products Due to Salmonella Risk

    MR Cuts, L.p. is recalling diced mango products sourced from Agricola Daniella due to potential Salmonella contamination. The products were distributed in Texas.

    Product
    Item # H996189 Mango Diced 1/2" 5 LB, Ingredients: Mango Packed By: Riley's Dallas, Texas 75226 Product of Mexico
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-804-2013·2013-07-24

    Fresenius Kabi Recalls Subpotent Oxytocin Injection Vials

    Fresenius Kabi is recalling 221,600 vials of Oxytocin Injection, USP, due to a subpotent drug issue identified during a 15-month stability test.

    Product
    Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V327000·2013-07-24

    Setra Recalls 2013 S417TC Buses Due to Rear Axle Bolt Issue

    Setra is recalling 2013 S417TC buses because a rear axle bolted joint could loosen, potentially reducing steering control and increasing crash risk.

    Product
    SETRA — SETRA S417 TC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1739-2013·2013-07-24

    St. Jude Medical Recalls Eon Mini Spinal Cord Stimulator Chargers

    St. Jude Medical is recalling Eon Mini chargers due to reports of skin burns and discomfort at the implant site during charging.

    Product
    Eon Mini - 3721 (Charger). Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1715-2013·2013-07-24

    Somersault Pacific Sea Salt Snacks Recalled for Flavor Mislabeling

    Somersault Snack Co. is recalling Pacific Sea Salt flavored nuggets because they were mispackaged with Santa Fe Salsa flavor. Consumers should check their packages for specific UPCs and sell-by dates.

    Product
    Somersault Pacific Sea Salt flavor, crunchy nuggets baked with sunflower seeds and toasted grains. 1 oz. packages sold in 6-count multi packs. Somersault Snacks co., LLC; Sausalito, Ca 94965
    Category
    Food
    Distribution
    17 states
  • SevereFDA (Drugs)·D-806-2013·2013-07-24

    Apotex Recalls Piperacillin and Tazobactam Injection Due to Crystallization Risk

    Apotex Corp. is recalling 37,303 vials of Piperacillin and Tazobactam for Injection due to a risk of precipitation or crystallization in IV bags or lines.

    Product
    Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-805-2013·2013-07-24

    Sandoz Recalls Estarylla Contraceptive Tablets Due to Placebo Tablet Error

    Sandoz Incorporated is recalling Estarylla tablets because a placebo tablet was found in a row of active tablets, which could reduce contraceptive effectiveness.

    Product
    Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·13V322000·2013-07-23

    Kenworth Recalls 2010-2012 T4 and W9 Series Vehicles for Fire Risk

    PACCAR is recalling 802 Kenworth T4 and W9 series vehicles because alternator wiring may contact the exhaust manifold, potentially causing a vehicle fire.

    Product
    KENWORTH — KENWORTH T4 SERIES, W9 SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·13244·2013-07-23

    Kids II Recalls Baby Einstein Activity Jumpers Due to Impact Hazard

    Kids II is recalling Baby Einstein Musical Motion Activity Jumpers because the sun toy attachment can snap backward and injure infants.

    Product
    Baby Einstein Musical Motion Activity Jumpers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V317000·2013-07-22

    Temsa Recalls 2013 TS30 Buses Due to Axle Shaft Breakage Risk

    Temsa is recalling 10 model year 2013 TS30 buses because improper heat treatment may cause axle shafts to break, increasing crash risk.

    Product
    TEMSA — TEMSA TS30
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V319000·2013-07-22

    Triumph Recalls 2012-2013 Motorcycles Due to ABS Malfunction Risk

    Triumph is recalling 1,887 model year 2012-2013 Street Triple and Daytona 675 motorcycles because the Anti-Lock Brake System may malfunction, increasing crash risk.

    Product
    TRIUMPH — TRIUMPH DAYTONA 675, STREET TRIPLE
    Category
    Vehicle
    Distribution
    Distributed nationwide