The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

30751–30775 of 50502

  • HighFDA (Devices)·Z-3148-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drills Due to Material Anomaly

    Zimmer Biomet is recalling 751 ECT Internal Fracture Fixation Drills because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Drill 1.1 mm Diameter (.043 Inch), Item Number/EDI 00231801100, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3176-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits

    Zimmer Biomet is recalling 381 ECT Internal Fracture Fixation Drill bits due to raw material anomalies that may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Drill 4.5 mm Diameter (.177 Inch), Item Number/EDI 00231804500, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3171-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits

    Zimmer Biomet is recalling 2,038 ECT Internal Fracture Fixation Drill Bits due to raw material anomalies that may increase the risk of instrument fracture.

    Product
    ECT Internal Fracture Fixation Drill Bits 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803206, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3233-2017·2017-10-04

    Sorin Platinium CRT-D Recall for Potential Overconsumption After ESD or MRI

    Sorin Group is recalling 68 Platinium CRT-D devices due to a possibility of overconsumption of the device following electrostatic discharge or an MRI scan.

    Product
    Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, 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
  • HighFDA (Devices)·Z-3161-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits

    Zimmer Biomet is recalling 439 ECT Internal Fracture Fixation Drill Bits due to raw material anomalies that may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Drill Bits 1.1 mm Diameter, Item Number/EDI 00231801106, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·18002·2017-10-04

    SRAM Recalls Avid SD7 Bicycle Brakes Due to Crash and Injury Hazards

    SRAM is recalling Avid SD7 bicycle brakes because a rivet can loosen, causing brake failure. Consumers should stop using them and contact SRAM for a free replacement.

    Product
    Bicycle brakes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3235-2017·2017-10-04

    Novadaq SPY-PHI PAQ Sterile Drape Recall Due to Pinholes

    Novadaq is recalling SPY-PHI PAQ kits because pinholes in the sterile drape may compromise the sterile barrier. The product is used in medical procedures.

    Product
    NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3149-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Surgical Instruments Due to Fracture Risk

    Zimmer Biomet is recalling 171 orthopedic surgical instruments 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, 2.7 mm Diameter, Item Number/EDI 00236015327, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3166-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drills Due to Material Anomaly

    Zimmer Biomet is recalling 3,232 ECT Internal Fracture Fixation Drills because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Drill 2.5 mm Diameter (.098 Inch), Item Number/EDI 00231802500, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3174-2017·2017-10-04

    Zimmer Biomet Recalls Straight Shank Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 173 nonsterile straight shank drill bits because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Straight Shank Drill Bit 4.0 mm Diameter, Item Number/EDI 00231804000, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3172-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drills Due to Material Anomaly

    Zimmer Biomet is recalling 356 ECT Internal Fracture Fixation Drills because a raw material anomaly may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Drill 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803500, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3232-2017·2017-10-04

    Sorin Platinium ICDs Recalled for Potential Overconsumption Risk

    Sorin Group is recalling Platinium ICDs and CRT-Ds due to a possibility of overconsumption following electrostatic discharge or MRI scans.

    Product
    Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, 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
  • HighFDA (Devices)·Z-3173-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits

    Zimmer Biomet is recalling 389 ECT Internal Fracture Fixation Drill Bits due to raw material anomalies that may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Drill Bits 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803506, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3177-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits

    Zimmer Biomet is recalling 217 nonsterile ECT Internal Fracture Fixation Drill Bits due to a raw material anomaly that may increase the risk of instrument fracture.

    Product
    ECT Internal Fracture Fixation Drill Bits 4.5 mm Diameter (.177 Inch), Item Number/EDI 00231804506, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3223-2017·2017-10-04

    Teleflex Percuvance Scissors Tool Tip Recall for Connection and Jaw Issues

    Teleflex Medical is recalling Percuvance Scissors Tool Tips because the shaft connection may be compromised or the jaws may close abruptly.

    Product
    Percuvance Scissors Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft…
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-3152-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 155 orthopedic drill bits and screw taps because raw material anomalies may cause the instruments to fracture during use.

    Product
    Drill Bit Jacobs Chuck 1.5 mm Diameter 70 mm Length, Item Number/EDI 00480507015, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3230-2017·2017-10-04

    Sorin Platinium ICDs Recalled for Potential Overconsumption Risk

    Sorin Group is recalling Platinium ICDs and CRT-Ds due to a possibility of overconsumption following electrostatic discharge or MRI scans.

    Product
    Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, 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
  • HighFDA (Devices)·Z-3155-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 224 sterile M/DN Intramedullary Fixation Distal Drills because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip, Item Number/EDI 47225503332, Sterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3186-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 240 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 2.7 mm Diameter 10 cm Length, Item Number/EDI 00241002700, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·18001·2017-10-03

    Playtex Recalls Children's Plates and Bowls Due to Choking Hazard

    Playtex is recalling approximately 3.6 million children's plates and bowls because the clear plastic layer can peel off, posing a choking hazard to young children.

    Product
    Children's Playtex plates and bowls
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17E058000·2017-10-03

    UD Recalls One Hino Engine for 2008 UD1800 Trucks Due to Wear Risk

    UD Trucks is recalling one Hino engine sold as a replacement for 2008 UD1800 trucks because shifting wrist pin bushings may cause excessive cylinder wear and engine failure.

    Product
    UD — UD UD1800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17E057000·2017-10-03

    NAPA and Evercraft 800lb Transmission Jacks Recalled for Bolt Failure

    International Specialty Services is recalling NAPA and Evercraft 800lb transmission jacks because a bolt may loosen, causing the saddle to destabilize and the transmission to tip over.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·105-2017·2017-10-03

    H-E-B Recalls Seasoned Diced Chicken Thighs for Undeclared Wheat Allergen

    H-E-B Meat Plant is recalling approximately 1,150 pounds of seasoned diced chicken thighs sold in Texas because the product contains wheat, an undeclared allergen.

    Product
    H-E-B Meat Plant Recalls Poultry Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·17E056000·2017-10-02

    Hale Products Recalls Firefighting Water Pump Retaining Rings

    Hale Products is recalling retaining rings for firefighting water pumps that may corrode and fail, reducing water pressure and hindering firefighting efforts.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide