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.

15401–15425 of 29202

  • SevereFDA (Devices)·Z-3196-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling specific orthopedic drill bits and screw taps because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Drill Bit Quick-Connect 3.5 mm Diameter 110 mm Length, Item Number/EDI 00480611035, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V618000·2017-10-04

    Prevost Recalls Motor Coaches Due to Fuel Tank Cradle Defect

    Prevost is recalling 2008-2018 motor coaches because fuel tank cradles may loosen, causing the tank to fall off and increasing crash risk.

    Product
    PREVOST — PREVOST X3-45 VIP ENTERTAINER, X3-45 VIP, XL2, H3-45 VIP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3106-2017·2017-10-04

    Spectranetics Bridge Occlusion Balloon Catheter Recalled for Guidewire Issues

    Spectranetics is recalling Bridge Occlusion Balloon catheters because the guidewire may not pass through the device, potentially delaying treatment.

    Product
    Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only. Product Usage: It is a device used to occlude the vessel and prevent blood loss as the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3175-2017·2017-10-04

    Zimmer Biomet Recalls Straight Shank Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 62 units of 4.0 mm Straight Shank Drill Bits because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Straight Shank Drill Bits 4.0 mm Diameter, Item Number/EDI 00231804006, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3202-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 150 nonsterile orthopedic drill bits because raw material anomalies may cause the instruments to fracture during use.

    Product
    Drill Bit Quick-Connect 4.5 mm Diameter 145 mm Length, Item Number/EDI 00480614545, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3199-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 15 nonsterile orthopedic drill bits because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Drill Bit Quick-Connect 3-Fluted 4.5 mm Diameter 195 mm Length, Item Number/EDI 00480719545, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3575-2017·2017-10-04

    Wegmans Dark Chocolate Cherry Cashew Granola Bars Recalled for Vitamin A

    Treehouse Foods is recalling Wegmans Dark Chocolate Cherry Cashew chewy granola bars because they may contain a higher concentration of Vitamin A than declared on the label.

    Product
    Wegmans Dark Chocolate Cherry Cashew chewy granola bars, 12-1.4OZ(40g) bars, Total Net Wt. 16.8OZ (1 LB 0.8OZ) 480g, UPC 77890-42230
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-3231-2017·2017-10-04

    Sorin Platinium VR ICDs Recalled for Potential Overconsumption Risk

    Sorin Group is recalling 72 Platinium VR implantable cardioverter defibrillators due to a possibility of overconsumption following electrostatic discharge or MRI scans.

    Product
    Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3167-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fixation Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling ECT Internal Fixation Drill Bits because raw material anomalies may cause the instruments to fracture during use.

    Product
    ECT Internal Fixation Drill Bits 2.5 mm Diameter (0.98 Inch), Item Number/EDI 00231802506, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3158-2017·2017-10-04

    Zimmer Biomet Recalls M/DN Intramedullary Fixation Distal Drill Pilot Tips

    Zimmer Biomet is recalling 182 M/DN Intramedullary Fixation Distal Drill Pilot Tips due to raw material anomalies that may increase the risk of instrument fracture.

    Product
    M/DN Intramedullary Fixation Distal Drill Pilot Tip 3.2 mm Diameter, Item Number/EDI 00225503332, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V617000·2017-10-04

    Hyundai Sonata Seat Belt Linkage Recall for Detachment Risk

    Hyundai is recalling 2011-2015 Sonata and Sonata Hybrid vehicles previously repaired under a prior campaign because seat belt linkages may detach from pretensioners, increasing injury risk in a crash.

    Product
    HYUNDAI — HYUNDAI SONATA HYBRID, SONATA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3228-2017·2017-10-04

    Sorin Platinium VR ICDs Recalled for Potential Overconsumption Risk

    Sorin Group is recalling Platinium VR implantable cardioverter defibrillators due to a possibility of overconsumption following electrostatic discharge or MRI scans.

    Product
    Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3187-2017·2017-10-04

    Zimmer Biomet Recalls ECT Quick-Connect Drills Due to Fracture Risk

    Zimmer Biomet is recalling 62 ECT Internal Fracture Fixation Quick-Connect Drills because raw material anomalies may cause the instruments to fracture during use.

    Product
    ECT Internal Fracture Fixation Quick-Connect Drill 3.5 mm Diameter 11 cm Length, Item Number/EDI 00241003500, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V619000·2017-10-04

    Lexus Recalls 2010 HS 250h Hybrid for Transaxle Short Circuit Risk

    Toyota is recalling 2010 Lexus HS 250h Hybrid vehicles because a hybrid transaxle component may short circuit, causing a loss of power and increasing crash risk.

    Product
    LEXUS — LEXUS HS 250 HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3191-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling specific orthopedic drill bits and screw taps because raw material anomalies may cause the instruments to fracture during use.

    Product
    Drill Bit Jacobs Chuck 3.2 mm Diameter 130 mm Length, Item Number/EDI 00480513032, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3188-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Quick-Connect Drill Bits

    Zimmer Biomet is recalling 10 units of ECT Internal Fracture Fixation Quick-Connect Drills due to a raw material anomaly that may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Quick-Connect Drill 4.0 mm Diameter 20cm Length, Item Number/EDI 00241004000, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3157-2017·2017-10-04

    Zimmer Biomet Recalls NCB Periprosthetic Plate System Drill Bits

    Zimmer Biomet is recalling 185 NCB Periprosthetic Plate System Drill Bits due to a raw material anomaly that may increase the risk of instrument fracture during use.

    Product
    NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 4.5 mm Diameter 195 mm Length, Item Number/EDI 0200024330, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V620000·2017-10-04

    Grand Design Recalls 2017-2018 Imagine Trailers for Fire Risk

    Grand Design RV is recalling 2017-2018 Imagine recreational trailers because air conditioning wires may detach and short circuit, increasing fire risk.

    Product
    GRAND DESIGN — GRAND DESIGN IMAGINE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3150-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Quick-Connect Drills

    Zimmer Biomet is recalling 4 units of ECT Internal Fracture Fixation Quick-Connect Drills due to raw material anomalies that may increase the risk of instrument fracture.

    Product
    ECT Internal Fracture Fixation Quick-Connect Drill, 1.5 mm Diameter, 85mm Length, Item Number/EDI 00241001500, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3178-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Screw Taps Due to Material Anomaly

    Zimmer Biomet is recalling 198 nonsterile orthopedic screw taps because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-Connect 3.5 mm Diameter, Item Number/EDI 00236015335, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3160-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Surgical Instruments Due to Fracture Risk

    Zimmer Biomet is recalling 21 units of M/DN Intramedullary Fixation Femoral Drills because raw material anomalies may cause the instruments to fracture during use.

    Product
    M/DN Intramedullary Fixation Femoral Drill Large 5.0 mm Item Number/EDI 00225503550, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3180-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Surgical Drills Due to Fracture Risk

    Zimmer Biomet is recalling 1,091 nonsterile orthopedic surgical drills and screw taps because raw material anomalies may cause instrument fracture.

    Product
    Zimmer Periarticular Locking Plate System Drill Standard 2.0 mm Diameter, Item Number/EDI 00236017520, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3193-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling specific orthopedic drill bits and screw taps because a raw material anomaly may increase the risk of instrument fracture during use.

    Product
    Drill Bit Quick-Connect 2.0 mm Diameter 100 mm Length, Item Number/EDI 00480610020, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·106-2017·2017-10-04

    Thompson's Ground Beef Recalled for Possible E. coli O157:H7 Contamination

    Clair D. Thompson & Sons, Inc. is recalling approximately 700 pounds of ground beef products due to possible E. coli O157:H7 contamination.

    Product
    Clair D. Thompson & Sons, Inc. Recalls Ground Beef Products Due To Possible E. Coli O157:H7 Contamination
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·17V616000·2017-10-03

    Braun Recalls 2016 BraunAbility MXV Vehicles Due to Airbag Sensor Defect

    Braun is recalling 2016 BraunAbility MXV wheelchair accessible vehicles because a seat position sensor may dislodge, potentially causing the frontal airbag to deploy with improper force.

    Product
    BRAUN — BRAUN BRAUNABILITY MXV
    Category
    Vehicle
    Distribution
    Distributed nationwide