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.

27701–27725 of 32222

  • SevereCPSC·13264·2013-08-15

    Char-Broil Recalls Patio Bistro Gas Grills Due to Burn Hazard

    Char-Broil is recalling about 69,300 Patio Bistro gas grills in the U.S. because the electronic ignition can unexpectedly reignite, posing a burn hazard.

    Product
    Char-Broil® Gas Patio Bistro® Grills
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·13267·2013-08-15

    Black & Decker Spacemaker Coffeemakers Recalled for Handle Breakage and Burn Risk

    Applica Consumer Products is reannouncing a recall for Black & Decker Spacemaker 12-Cup Coffeemakers because the handle can break, causing cuts and burns.

    Product
    Black & Decker® Spacemaker™ 12-Cup Programmable Under-the-Cabinet Coffeemakers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V360000·2013-08-15

    GM Recalls 2011-2012 Chevrolet Cruze for Brake Assist Defect

    General Motors is recalling 2011-2012 Chevrolet Cruze vehicles because the electric vacuum pump may fail, reducing brake assist and increasing crash risk.

    Product
    CHEVROLET — CHEVROLET CRUZE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-841-2013·2013-08-14

    Sanofi Recalls Subpotent Rifadin Rifampin Capsules Due to Low Fill Volume

    Sanofi US is recalling 2,462 bottles of Rifadin (Rifampin) 150 mg capsules because some capsules contain low fill volume, resulting in subpotent drug.

    Product
    Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for Sanofi-Aventis, U.S., LLC, Bridgewater, NJ 08807, NDC 0068-0510-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V358000·2013-08-14

    Fiat Recalls 2013 500e Electric Vehicles for Half Shaft Joint Defect

    Chrysler is recalling 491 model year 2013 Fiat 500e electric vehicles because half shaft joints may loosen and separate, causing a loss of driving capability and increasing crash risk.

    Product
    FIAT — FIAT 500E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1857-2013·2013-08-14

    Hospira Recalls Y-Type Blood Sets Due to Piercing Pin Defect

    Hospira Inc. is recalling 1,104 Y-type blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.

    Product
    List No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter, Prepierced Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-838-2013·2013-08-14

    Zydus Recalls Warfarin Sodium Tablets Due to Oversized Pills

    Zydus Pharmaceuticals is recalling 960 bottles of Warfarin Sodium Tablets 2 mg because a pharmacist found three oversized tablets in one bottle.

    Product
    Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1852-2013·2013-08-14

    Hospira Recalls Y-Type Blood Sets Due to Potential Bag Puncture

    Hospira is recalling 1,976 Y-type blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.

    Product
    List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Convertible Pin and Non-Vented Pin, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-832-2013·2013-08-14

    Sandoz Recalls Methotrexate Injection Vials Due to Particulate Matter

    Sandoz Incorporated is recalling specific lots of Methotrexate Injection vials because particulate matter was found in retention samples.

    Product
    Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540; Manufactured by: EBEWE Pharma Ges.m.b.H. Nfg.KG, A-4866 Unterach, AUSTRIA, NDC 66758-041-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1855-2013·2013-08-14

    Hospira Recalls Blood Sets Due to Potential Bag Puncture Risk

    Hospira is recalling specific blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.

    Product
    List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0476-2013·2013-08-14

    ArjoHuntleigh Recalls Enterprise 8000 Hospital Beds Due to Unintended Movement

    ArjoHuntleigh is recalling Enterprise 8000 hospital beds because the backrest or thigh sections may move without user input, posing a risk to patients in high-dependency care.

    Product
    Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0477-2013·2013-08-14

    Arjo Enterprise 9000 Hospital Beds Recalled for Unintended Movement

    ArjoHuntleigh is recalling Enterprise 9000 hospital beds because the backrest or thigh sections may move without user input, posing a risk to patients in high-dependency care.

    Product
    Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electronic weigh scale, patient bed exit alarm, and under bed anti-entrapment system; ArjoHuntleigh AB, Eslov, Sweden; Models 9000, 9600, 9700 and 9800 General medicine, general and specialist surgery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1851-2013·2013-08-14

    Hospira Blood Sets Recalled Due to Potential Bag Puncture Risk

    Hospira is recalling 1,152 blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.

    Product
    List No. 14203-28; BLOOD SET; 200 Micron Filter, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1795-2013·2013-08-14

    Superior Nut Co. Recalls Raw Pistachio Halves Due to Salmonella Risk

    Superior Nut Co. Inc. is recalling raw pistachio halves after a positive laboratory test for Salmonella. The recall covers multiple bag sizes distributed nationwide and in Canada.

    Product
    Raw Pistachio Halves, 1 pound bag. Item Number 11910, UPC Code: 172043119107; Raw Pistachio Halves, 4 pound bag. Item Number 11911, UPC Code: 172043119114; Raw Pistachio Halves, 10 pound bag in box. Item Number 11912, UPC Code: 172043119121; Raw Pistachio Halves, 25 pound…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-835-2013·2013-08-14

    Apotex Recalls Piperacillin and Tazobactam Injection Due to Crystallization Risk

    Apotex Corp. is recalling 52,398 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 (Devices)·Z-1858-2013·2013-08-14

    Hospira Recalls Y-Type Blood Sets Due to Potential Bag Puncture

    Hospira Inc. is recalling 3,600 units of Y-Type Blood Sets because the piercing pin may puncture the outer wall of blood bags during insertion.

    Product
    List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-840-2013·2013-08-14

    AstraZeneca Recalls Merrem I.V. Vials Due to Precipitate Presence

    AstraZeneca is recalling specific lots of Merrem I.V. (meropenem) because of precipitate presence, which may prevent the medication from mixing completely.

    Product
    MERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial, Rx only, Mfd for: AstraZeneca Pharmaceuticals LP, Wilmington, DE by ACS Dobfar SpA Viale Addetta, Tribiano, Milano Italy NDC 0310 0321 30
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1856-2013·2013-08-14

    Hospira Recalls Blood Sets Due to Potential Bag Puncture Risk

    Hospira Inc. is recalling specific blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.

    Product
    List No. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1850-2013·2013-08-14

    Hospira Recalls Secondary Blood Sets Due to Piercing Pin Defect

    Hospira Inc. is recalling 672 units of secondary blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.

    Product
    List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1854-2013·2013-08-14

    Hospira Recalls Blood Sets Due to Potential Puncture of Blood Bags

    Hospira Inc. is recalling 96 units of PLUM BLOOD SETS because the piercing pin may puncture the outer wall of blood bags during insertion.

    Product
    List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection Site, 170 Micron Filter, Prepierced Port, Non-Vented, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-852-2013·2013-08-14

    Apotex Recalls Latanoprost Ophthalmic Solution Due to Sterility Concerns

    Apotex Inc. is recalling Latanoprost Ophthalmic Solution, 0.005%, because it failed a preservative effectiveness test, raising concerns about potential microbial growth.

    Product
    Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario Canada M9L 1T9; Manufactured for: Apotex Corp., Weston, FL 33326; NDC 60505-0565-1; UPC 3 60505 05651 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1874-2013·2013-08-14

    Iradimed MRidium Dose Reduction System Recall for Infusion Rate Errors

    Iradimed is recalling MRidium 1145 Dose Reduction System kits because they may display incorrect infusion rates, posing a risk of over- or under-infusion.

    Product
    MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·13747·2013-08-14

    John Deere Recalls Compact Utility Tractors Due to ROPS Pin Failure Risk

    John Deere is recalling about 7,000 compact utility tractors because spring locking pins in the rollover protective system can break, posing a risk of serious injury or death.

    Product
    John Deere Compact Utility Tractors
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·13748·2013-08-14

    LTD Commodities Recalls Microwave Crisper Pans Due to Fire Hazard

    LTD Commodities is recalling microwave crisper pans because a metal washer can spark, posing a fire hazard. The firm reported 16 incidents involving sparks, flames, or shattered glass.

    Product
    Microwave Crisper Pan with Lids
    Category
    Consumer Product
    Distribution
    Distributed nationwide