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.

21451–21475 of 50426

  • HighFDA (Devices)·Z-0644-2021·2020-12-30

    GA Health Recalls Andorate Disposable Endoscope Valves Due to Defective Suction Button

    GA Health Company Limited is recalling 93,700 units of Andorate Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging medical procedures.

    Product
    Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0712-2021·2020-12-30

    Baxter SIGMA Spectrum Infusion Pump Recalled for Potential Software Error

    Baxter Healthcare is recalling 9,353 SIGMA Spectrum Infusion Pumps due to a potential software error during programming.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V814000·2020-12-28

    Yamaha Motorcycles Recalled for Front Brake Switch Failure

    Yamaha is recalling motorcycles for a front brake switch defect that can keep the brake light on or cause unexpected cruise control shutoff, increasing crash risk. Contact Yamaha customer service at 1-800-962-7926 for a free replacement.

    Product
    YAMAHA — YAMAHA FJR1300, XTZ12, XV1900, MT-10
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0622-2021·2020-12-23

    Biomet M/H Modular Stem Recalled for Potential Sterile Seal Breach

    Biomet, Inc. is recalling 7,428 units of the M/H Modular Stem (Item 13-104756) because a breach in the sterile seal could lead to loss of sterility.

    Product
    M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb salvage procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0619-2021·2020-12-23

    Biomet Reverse Shoulder System Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of the Comprehensive Reverse Shoulder System because a breach in the sterile seal could lead to loss of sterility.

    Product
    Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: indicated for use in patients whose shoulder joint has a grossly deficient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0627-2021·2020-12-23

    Biomet Ringloc Acetabular System Screws Recalled for Sterile Seal Breach

    Biomet is recalling specific lots of Ringloc Acetabular System self-tapping bone screws because a breach in the sterile seal could lead to loss of sterility.

    Product
    RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0630-2021·2020-12-23

    Biomet Recalls Titanium IFS Devices Due to Potential Sterile Seal Breach

    Biomet, Inc. is recalling 7,428 units of Titanium IFS devices (Item 909680) because a breach in the sterile seal could lead to loss of sterility.

    Product
    Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0618-2021·2020-12-23

    Biomet Cannulated Screw System Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of cannulated screw systems because a breach in the sterile seal could lead to loss of sterility.

    Product
    6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009929, 110009934, 110009935, 110009936, 110009993, 110009994, 110009996, 110009998, 110010000, 110010003, 110010029, 110010030, 110010032, 110010099 - Product Usage…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0625-2021·2020-12-23

    Biomet Phoenix Interlocking Screws Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of Phoenix interlocking screws because a breach in the sterile seal could lead to loss of sterility.

    Product
    PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-405044, 14-405070 - Product Usage: Fracture fixation of small bones, small bone fragements and long bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0626-2021·2020-12-23

    Biomet RapidFire Clip Recall Due to Potential Sterile Seal Breach

    Biomet is recalling specific lots of RapidFire Clips used for craniofacial bone fixation because a breach in the sterile seal could lead to loss of sterility.

    Product
    RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofacial bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0631-2021·2020-12-23

    Biomet RingLoc+ Drill Bits Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of RingLoc+ Quick Connect Drill Bits because a breach in the sterile seal could lead to loss of sterility.

    Product
    RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323230, 31-323240 - Product Usage: Bit, Drill.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0616-2021·2020-12-23

    Biomet Recalls Cannulated Screw Systems Due to Potential Sterile Seal Breach

    Biomet is recalling specific lots of cannulated screw systems because a breach in the sterile seal could lead to loss of sterility.

    Product
    3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787 110009790, 110009794, 110009796, 110009798, 110009800 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0624-2021·2020-12-23

    Biomet Oxford Fixed Lateral Knee Implants Recalled for Sterile Seal Breach

    Biomet is recalling specific lots of Oxford Fixed Lateral knee implants because a breach in the sterile seal could lead to loss of sterility.

    Product
    Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral compartment and intended to be implanted with bone cement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0161-2021·2020-12-23

    CitruGel Hand Sanitizer Recalled for Subpotent Drug Content

    Simex Logistics SA de CV is voluntarily recalling 1,800 bottles of CitruGel Hand Sanitizer because the product is subpotent.

    Product
    CitruGel Hand Sanitizer Advanced Formula 70% Alcohol Fresh Lemon Scent, 33.81 FL OZ (1L), Distributed By Citru Gel Inc. Henderson, NV 89052 www.citrugel.com NDC: 78247-002-01
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0564-2021·2020-12-23

    FDA Recalls Tempus LS Manual Defibrillators Due to Software Error

    Remote Diagnostic Technologies is recalling 175 Tempus LS manual defibrillators because a software error may delay therapy by disrupting ECG calibration.

    Product
    Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0590-2021·2020-12-23

    Enterix Recalls InSure ONE Test Strips Due to Potential False Positives

    Enterix, Inc. is recalling InSure ONE Test Strips because they may produce false positive results, potentially leading to unnecessary medical procedures.

    Product
    InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0589-2021·2020-12-23

    RaySearch Recalls RayStation and RayPlan Software Due to Treatment Plan Errors

    RaySearch is recalling RayStation and RayPlan software versions due to potential errors in treatment plan reports, including incorrect dose information and couch angles.

    Product
    RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also affected, but not the 10A service pack. (Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21057·2020-12-23

    GSK Recalls Five Excedrin Brands Due to Child-Resistant Packaging Defects

    GSK Consumer Healthcare is recalling five Excedrin brands because some bottles have holes in the bottom, posing a risk of poisoning to children.

    Product
    Excedrin Migraine Caplets, Excedrin Migraine Geltabs, Excedrin Extra Strength Caplets, Excedrin PM Headache Caplets, and Excedrin Tension Headache Caplets
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0569-2021·2020-12-23

    Ra Medical Systems Recalls DABRA Laser Due to Footswitch Defect

    Ra Medical Systems is recalling 36 DABRA Laser devices because the footswitch may fail to protect against liquid ingress, potentially causing the laser to remain on.

    Product
    DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0623-2021·2020-12-23

    Biomet OSS Polyethylene Tibial Bushing Recalled for Sterile Seal Breach

    Biomet is recalling specific lots of OSS Polyethylene Tibial Bushings because a breach in the sterile seal could lead to loss of sterility.

    Product
    OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0613-2021·2020-12-23

    Carl Zeiss Meditec VISULENS 550 Recalled for Electrical Shock Risk

    Carl Zeiss Meditec is recalling VISULENS 550 refractive power measurement devices due to a defective communication board that may cause electrical shocks.

    Product
    Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of contact lenses and spectacle lenses and displaying measurement values for sphere, cylinder and prism.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0629-2021·2020-12-23

    Biomet Recalls Sterile Trac System Thinflap Burr Hole Plates

    Biomet is recalling specific lots of Sterile Trac System Thinflap 24 MM Burr Hole Plates because a breach in the sterile seal could lead to loss of sterility.

    Product
    Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0620-2021·2020-12-23

    Biomet Shoulder System Surgical Handles Recalled for Sterile Seal Breach

    Biomet is recalling specific lots of sterile shoulder system surgical instrument handles because a breach in the packaging seal could lead to loss of sterility.

    Product
    Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical instrument handle, non-torque-limiting.
    Category
    Medical Device
    Distribution
    Distributed nationwide