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.

17726–17750 of 29217

  • SevereFDA (Devices)·Z-2702-2016·2016-09-14

    MicroPort Recalls Advance II Modular Tibial Bases Due to Component Loosening

    MicroPort Orthopedics is recalling 47 units of Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.

    Product
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA51, SIZE 5+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2716-2016·2016-09-14

    Aribex Recalls NOMAD Pro X-Ray Systems Due to Battery Fire Risk

    Aribex Inc is recalling NOMAD Pro X-Ray systems because internal lithium-ion batteries may short-circuit, causing overheating, melting, smoking, or ignition.

    Product
    NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part Number 08500011; NOMAD Pro Packaged X-Ray System - Europe, Part Number 08500013; NOMAD Pro X-Ray System, Remote Config., Part Number 08500017; NOMAD Pro Packaged X-Ray System JP…
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Drugs)·D-1495-2016·2016-09-14

    Teva Recalls Linezolid Injection Due to Manufacturing Deviations

    Teva North America is voluntarily recalling 92,480 containers of Linezolid Injection 600 mg/300 mL due to CGMP deviations. The recall covers products distributed nationwide and in Puerto Rico.

    Product
    Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-9060-31- (Single Use Container), NDC# 0703-9060-33 (Box of 10 Singe Use Containers)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2703-2016·2016-09-14

    MicroPort Recalls Advance II Modular Tibial Bases Due to Component Loosening

    MicroPort Orthopedics is recalling 38 units of Advance II Modular Tibial Bases because they are experiencing a higher than expected revision rate due to component loosening.

    Product
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA60, SIZE 6 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 6 FEMUR & SIZE 6 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2693-2016·2016-09-14

    MicroPort Advance II Tibial Base Recalled for Component Loosening

    MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.

    Product
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA10, SIZE 1 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2695-2016·2016-09-14

    MicroPort Advance II Modular Tibial Base Recalled for Component Loosening

    MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.

    Product
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA20, SIZE 2 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2699-2016·2016-09-14

    MicroPort Recalls Advance II Modular Tibial Base Components

    MicroPort Orthopedics is recalling Advance II Modular Tibial Base components due to a higher than expected revision rate caused by component loosening.

    Product
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA40, SIZE 4 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total…
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·16V662000·2016-09-14

    Gillig Recalls 2014-2016 Low Floor Buses Due to Brake Hose Fraying

    Gillig is recalling 2014-2016 Low Floor transit buses because rear brake hoses can fray, potentially causing brake lockup or failure and increasing crash risk.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2697-2016·2016-09-14

    MicroPort Advance II Modular Tibial Base Recalled for Component Loosening

    MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.

    Product
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA30, SIZE 3 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FEMUR & SIZE 3 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2768-2016·2016-09-14

    Bayer Certegra Workstation Recalled for Fire and Smoke Risk

    Bayer Healthcare is recalling 165 Certegra Workstations used with Medrad Stellant CT Injection Systems because they may produce smoke and sparks of fire.

    Product
    Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1586-2016·2016-09-14

    Schnucks Recalls Maytag Blue Cheese Due to Listeria Risk

    Schnucks Markets is recalling Maytag Blue cheese cut and wrapped in-store due to potential Listeria monocytogenes contamination. The product was sold in Missouri, Illinois, and Iowa.

    Product
    Maytag Blue cheese cut and wrapped in clear plastic wrap at store level, sold in various sizes (approximately 3-4 oz pieces), labeled with company issued Maytag Blue cheese label and Schnuck Markets scale label, UPC 0021806200000.
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·16V658000·2016-09-13

    Freightliner Trucks Recalled for Brake Caliper Bolt Torque Issues

    Daimler Trucks North America is recalling 2016-2017 Freightliner M2 and 114 SD trucks because brake caliper mounting bolts may be incorrectly torqued, potentially reducing braking ability.

    Product
    FREIGHTLINER — FREIGHTLINER 114SD, BUSINESS CLASS M2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E071000·2016-09-13

    EVS Emergency Vehicle Seats Recalled for Slide Track Defect

    EVS is recalling emergency vehicle seats with Dometic/Atwood slide tracks that may not engage properly, increasing injury risk in a crash.

    Product
    SEATS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V654000·2016-09-12

    FCCC Motorhome Chassis Recall for Brake Signal Defect

    Daimler Trucks is recalling 2013-2016 FCCC XCM, XCR, and XCL motorhome chassis because a brake signal may remain active, causing towed device brakes to drag and potentially overheat.

    Product
    FCCC — FCCC XCL, XCR, XCM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V653000·2016-09-09

    BMW Recalls M2, M3, and M4 Models for Rear Sub-Frame Bolt Issue

    BMW is recalling specific M2, M3, and M4 vehicles because reused rear sub-frame bolts may loosen, affecting handling and increasing crash risk.

    Product
    BMW — BMW M4, M2, M3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·077-2016·2016-09-08

    Carnival Supermarket Recalls Ground Beef Due To E. Coli O157:H7

    Carnival Supermarket in Chula Vista, California, is recalling approximately 35 pounds of ground beef sold on Sept. 1, 2016, due to possible E. coli O157:H7 contamination.

    Product
    Paradise Valley Market, Inc. (Carnival Supermarket) Recalls Ground Beef Productsdue To Possible E. Coli O157:H7 Adulteration
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V652000·2016-09-08

    Cambli Recalls 2014-2015 Beverage Industry Trailers Due to Brake Defect

    Cambli is recalling 2014-2015 Beverage Industry trailers because improperly machined spring brake valves may delay braking, causing the trailer to roll away.

    Product
    CAMBLI — CAMBLI BEVERAGE INDUSTRY TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V648000·2016-09-08

    Audi Recalls 2017 Q7 Vehicles Due to Electric Power Steering Defect

    Volkswagen Group of America is recalling 2017 Audi Q7 vehicles because the electric power steering control unit may short circuit, causing a loss of steering assist and increasing crash risk.

    Product
    AUDI — AUDI Q7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2675-2016·2016-09-07

    Intuitive Surgical da Vinci EndoWrist Stapler 45 Recall for Field Failures

    Intuitive Surgical is recalling da Vinci EndoWrist Stapler 45 instruments due to reported field failures involving shaft rotation interruptions and jaw opening issues.

    Product
    STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2007-2016·2016-09-07

    Raw Pistachio Kernels Recalled Due to Salmonella Contamination

    International Foodsource LLC is recalling 9,756 bags of Valued Natural Raw Pistachio Kernels due to potential Salmonella contamination.

    Product
    Valued Natural Raw Pistachio Kernels Net Wt 5 oz. (141 g) International Foodsource LLC 52 Richboynton, Rd. Dover, NJ 07801 UPC 790429241428
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2036-2016·2016-09-07

    Warren Produce Recalls Serrano Peppers Due to Salmonella Contamination

    Warren Produce is recalling 14,000 pounds of Primo Fresh Serrano Peppers because the product tested positive for Salmonella.

    Product
    Primo Fresh Serrano Peppers Distributed by Warren Produce, 824 W. Monte Cristo Rd, Edinburg, TX packaged in 1/4 bushel waxed cardboard boxes, 1 1/9 bushel waxed cardboard boxes, 10 lb waxed cardboard boxes, 5 lb waxed cardboard boxes and 35 lb RPC crates.
    Category
    Food
    Distribution
    10 states