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.

16501–16525 of 29206

  • SevereFDA (Devices)·Z-1167-2017·2017-03-01

    Biomet Recalls Oxford Knee Instruments Due to Material Inclusions

    Biomet U.K. is recalling Oxford Partial Knee instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Left Medial Tibial Trial Tray Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Devices)·Z-1164-2017·2017-03-01

    Biomet Recalls Oxford Partial Knee Instruments Due to Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Drugs)·D-0482-2017·2017-03-01

    RemedyRepack Recalls Glipizide Tablets for Failed Dissolution Specifications

    RemedyRepack Inc. is recalling Glipizide 2.5 mg ER tablets because they failed to meet dissolution specifications. The product was distributed to a customer in Florida.

    Product
    Glipizide 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsippany, NJ 07054, Repackaged by RemedyRepack, Indiana, PA 15701, NDC 52125-0764-02
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0480-2017·2017-03-01

    Hospira Recalls Metronidazole Injection Bags Due to Leaking

    Hospira is recalling 578,784 bags of Metronidazole Injection due to a customer report of a leaking bag, which compromises sterility assurance.

    Product
    METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc., Lake Forest, IL --- NDC 0409-7811-24
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·019-2017·2017-03-01

    Dos Hermanos Recalls Beef Jerky Produced Without Federal Inspection

    Dos Hermanos, Inc. is recalling approximately 151 pounds of Carne Seca Beef Jerky produced without federal inspection. The products were distributed in Illinois, Iowa, Kansas, and Missouri.

    Product
    Dos Hermanos, Inc. Recalls Beef Jerky Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    4 states
  • SevereCPSC·17098·2017-02-28

    S.R. Smith Recalls Helix Pool Slides Due to Fall Hazard

    S.R. Smith is recalling Helix pool slides because children can fall off the side before reaching the pool, posing a risk of serious injury.

    Product
    Helix pool slides
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·017-2017·2017-02-28

    Wayne Farms Recalls Ready-to-Eat Chicken Bites Due to Processing Defect

    Wayne Farms is recalling approximately 12,610 pounds of ready-to-eat chicken bites due to a potential processing defect that may allow bacterial pathogens to survive.

    Product
    Wayne Farms LLC — Wayne Farms, LLC Recalls Ready-To-Eat Chicken Products Due To Potential Processing Deviation
    Category
    Food
    Distribution
    10 states
  • SevereUSDA FSIS·016-2017·2017-02-28

    Gourmet Classic Salads Recalls Ready-To-Eat Meat and Poultry Products

    Gourmet Classic Salads is recalling approximately 3,236 pounds of ready-to-eat meat and poultry products due to possible Listeria monocytogenes contamination.

    Product
    Gourmet Classic Salads, Inc Recalls Ready-To-Eat Meat and Poultry Products Due To Possible Listeria Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·17V124000·2017-02-27

    Western Star 4900 Trucks Recalled for Air Tank Weld Defects

    Daimler Trucks North America is recalling 2015-2018 Western Star 4900 trucks because aluminum air tanks may have improper welds, risking rapid air pressure loss.

    Product
    WESTERN STAR — WESTERN STAR 4900
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V126000·2017-02-27

    Thomas Built Buses Recalls Saf-T-Liner HDX for Steering Defect

    Daimler Trucks North America is recalling 2017-2018 Thomas Built Buses Saf-T-Liner HDX transit buses because a loose steering pinch bolt may cause loss of vehicle control.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V123000·2017-02-27

    Ford Recalls 2016-2017 Edge, MKX, Continental for Air Bag Defect

    Ford is recalling 2016-2017 Edge, MKX, and Continental vehicles because the driver's air bag may not fully inflate or detach during a crash.

    Product
    LINCOLN — LINCOLN, FORD MKX, CONTINENTAL, EDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V122000·2017-02-27

    Horton Ambulances Recalled for Rear Brake Bolt Torque Issue

    Halcore Group is recalling 2017 Horton ambulances because overtightened rear brake bolts may cause loss of braking power, increasing crash risk.

    Product
    HORTON AMBULANCE — HORTON AMBULANCE CCO, 453, 623, 457
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V125000·2017-02-27

    Thomas Built Buses Recalls 2017-2018 Saf-T-Liner HDX School Buses

    Daimler Trucks North America is recalling 2017-2018 Thomas Built Buses Saf-T-Liner HDX school buses because a loose steering bolt may cause loss of vehicle control.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V117000·2017-02-24

    Forest River Recalls 2017 Sandstorm and Stealth RVs for Propane Leak Risk

    Forest River is recalling 2017 Sandstorm and Stealth recreational vehicles because the liquid propane line may be damaged by the axle, creating a fire or explosion hazard.

    Product
    FOREST RIVER — FOREST RIVER SANDSTORM, STEALTH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V118000·2017-02-24

    Forest River Recalls 2017 Wildwood and Salem Trailers Due to Propane Leak Risk

    Forest River is recalling 2017 Wildwood and Salem recreational trailers because an improperly installed refrigerator vent allows propane gas to enter the vehicle, increasing the risk of fire or explosion.

    Product
    FOREST RIVER — FOREST RIVER WILDWOOD, SALEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·17096·2017-02-23

    Little Tikes Recalls Toddler Swings Due to Fall Hazard

    Little Tikes is recalling about 540,000 2-in-1 Snug 'n Secure Pink toddler swings because the plastic seat can crack or break, posing a fall hazard.

    Product
    Little Tikes™ 2-in-1 Snug 'n Secure Pink toddler swings
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·17094·2017-02-23

    Carrier Recalls Packaged Terminal Air Conditioners and Heat Pumps Due to Fire Hazard

    Carrier is expanding a recall for about 94,000 packaged terminal air conditioners and heat pumps because the power cord plug can overheat, posing a fire hazard.

    Product
    Packaged Terminal Air Conditioners (PTAC) and Packaged Terminal Heat Pumps (PTHP)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1188-2017·2017-02-22

    GE Healthcare Recalls Discovery MR450 MRI Scanners Due to Burn Risk

    GE Healthcare is recalling 60 Discovery MR450 MRI scanners because a component failure can cause the patient bore to heat up, potentially leading to serious burns.

    Product
    Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1192-2017·2017-02-22

    Integra Cadence Total Ankle System Recalled Due to Tibial Fractures

    Integra LifeSciences Corp. is recalling 944 units of the Cadence Total Ankle System because posterior tibial fractures have been reported.

    Product
    Integra Cadence Total Ankle System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1215-2017·2017-02-22

    Siemens PRIMUS Radiation Therapy Systems Recalled for Collimator and Weld Defects

    Siemens is recalling 194 PRIMUS radiation therapy systems due to incorrect collimator position displays and improper weld seams at the overhead suspension.

    Product
    PRIMUS Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1193-2017·2017-02-22

    Stryker Restoris RIO Reamer Handle Recalled for Engagement Failure

    Mako Surgical Corporation is recalling 595 Stryker Restoris RIO Reamer Handles because they may fail to engage mating components during surgery.

    Product
    Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide