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.

12501–12525 of 22165

  • HighFDA (Devices)·Z-1141-2024·2024-02-21

    HeartSine Samaritan PAD Defibrillators Recalled for Test Configuration Flaw

    HeartSine samaritan PAD defibrillators shipped in test configuration may have incorrect CPR timing and delayed or no therapy delivery in cardiac events. Users should stop using affected units and contact the manufacturer.

    Product
    HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-08, ; SAM 500P/500-BAS-UK-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1068-2024·2024-02-21

    OriGen Biomedical Accessory Syringe Sets Recalled for Sterilization Incompatibility

    OriGen Biomedical is recalling 3,613 cases of accessory syringe sets due to design and material changes that caused loss of gamma sterilization compatibility, resulting in yellowed discoloration and unqualified product status.

    Product
    Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cm sealed SCD tubing, REF: 15-RF60-T
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1088-2024·2024-02-21

    Philips CombiDiagnost R90 Fluoroscopy Display May Show Previous Patient Images

    Philips CombiDiagnost R90 fluoroscopy systems may display a previous patient's images during radiography examination, potentially showing different image content, format, and size that could affect imaging accuracy.

    Product
    CombiDiagnost R90 1.1 (709031)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1077-2024·2024-02-21

    Medical Device Recall: Heart-Lung Machine Component Sterile Barrier Defect

    The BEQ-HLS 7050 USA HLS Set Advanced 7.0 is recalled due to a compromised sterile barrier on its Emergency Priming Line component. This defect may cause inflammation, sepsis, or infection.

    Product
    BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1072-2024·2024-02-21

    Philips ProxiDiagnost N90 X-ray System Recall for Patient Data and Security Issues

    Philips is recalling 138 U.S. units of its ProxiDiagnost N90 radiography system due to two identified issues. The system may display incorrect patient images during scan transitions, and a security vulnerability could allow unauthorized data access with physical device access.

    Product
    ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1056-2024·2024-02-21

    Samsung GM85 Mobile X-ray System Welding Frame Defect Arm Fall Risk

    NeuroLogica is recalling 261 Samsung GM85 mobile x-ray systems due to a welding defect in the moving arm frame that could cause the arm to fall, risking bodily injury.

    Product
    Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1089-2024·2024-02-21

    global Medium embryo culture media recalled for potential development impairment

    CooperSurgical is recalling three specific lots of global Medium embryo culture media distributed to fertility clinics worldwide due to performance issues that may impair embryo development during culture.

    Product
    global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1139-2024·2024-02-21

    BIOFIRE BCID2 Blood Culture Panel Recalled for False Positive Candida tropicalis Results

    BioFire Diagnostics recalls BIOFIRE BCID2 panels due to false positive Candida tropicalis detection when used with certain BD BACTEC culture vials. The vials contain non-viable organism DNA that triggers incorrect positive results.

    Product
    BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BD BACTEC Standard Aerobic medium BD BACTEC Standard Anaerobic medium The BIO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0871-2024·2024-02-21

    Dannon Plain Yogurt 32oz cartons recalled for potential sanitizer contamination

    DANONE US LLC is recalling Dannon Plain Yogurt 32oz cartons distributed in Georgia due to potential contamination with sanitizer. The affected product expires 03/13/24.

    Product
    Dannon Plain Yogurt packaged in 32oz plastic carton with lid - 6 cartons per case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1085-2024·2024-02-21

    Stryker Trevo Trak 21 Microcatheter Recalled for Unevaluated Intended Use

    Stryker, Inc. is recalling 63 units of the Trevo Trak 21 Microcatheter because the device instructions contain an intended use that has not been evaluated by the FDA.

    Product
    Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1083-2024·2024-02-21

    Portable X-ray system may move unexpectedly if improperly cleaned

    The MobileDiagnost wDR portable X-ray system may move unexpectedly if excessive liquid is used during cleaning. This affects 851 devices distributed nationwide.

    Product
    MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0325-2024·2024-02-21

    Vasopressin Compounded Injectable Syringes Recalled for Sub-Potency Failure

    IntegraDose Compounding Services is recalling Vasopressin injectable syringes because the medication may lose potency before its labeled expiration date, potentially leaving patients with reduced doses.

    Product
    Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71139-0190-1.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1067-2024·2024-02-21

    Bone void filler recalled due to manufacturing process control issue

    Musculoskeletal Transplant Foundation recalled 50 units of AFT Allograft Filler Tubes in Minnesota due to an unqualified manufacturing filling process. The product may have extrudability issues causing extended surgery time.

    Product
    AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1140-2024·2024-02-21

    FilmArray GI diagnostic kits recalled due to false positive Norovirus results

    BioFire Diagnostics is recalling FilmArray GI diagnostic test kits due to potential signals of increased false positive Norovirus results. Approximately 64,594 kits representing 2.3 million tests have been distributed worldwide.

    Product
    FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·24118·2024-02-15

    Bell Soquel Youth Bicycle Helmets Recalled for Head Injury Risk

    Bell Sports is recalling about 2,425 Bell Soquel Youth Helmets because the strap anchor can become dislodged during a crash, reducing protection and posing a risk of head injury.

    Product
    Bell Soquel Youth Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24120·2024-02-15

    FeraDyne Rhino Climbing Sticks Recalled Due to Fall and Laceration Risk

    FeraDyne Outdoors is recalling about 8,900 Rhino 24-foot Hot Foot Climbing Sticks because the sticks can break at the weld point, causing falls and cuts. The company has received nine reports of breakage, including three laceration injuries.

    Product
    Rhino 24-foot Hot Foot Climbing Sticks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24116·2024-02-15

    Char-Broil Digital Electric Smokers Recalled for Electric Shock Risk

    Char-Broil is recalling about 211,700 digital electric smokers that can leak electrical current during use, posing an electric shock hazard. The company has received 79 reports of consumers experiencing minor electric shocks, including one report of a finger blister.

    Product
    Digital Electric Smokers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24119·2024-02-15

    BRS and BULin Liquid Fuel Bottles Recalled for Burn and Poisoning Risk

    BRS and BULin portable liquid fuel bottles sold on Amazon.com do not have child-resistant closures and the BRS 530mL bottle lacks a flame mitigation device, posing risks of burn, poisoning, and flash fire.

    Product
    BRS and BULin Liquid Fuel Bottles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24117·2024-02-15

    Frigidaire Rear-Controlled Ranges Recalled for Electrical Shock and Electrocution Hazards

    Electrolux Group is recalling about 1,800 Frigidaire rear-controlled ranges because the control panel can detach from the unit, creating electrical shock and electrocution hazards. Consumers should stop using the ranges immediately and contact Electrolux for a free repair.

    Product
    Frigidaire rear-controlled ranges
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24121·2024-02-15

    Growing Table-Mini Greenhouse Recalled Due to Fire Hazard

    Ocean State Job Lot is recalling approximately 12,800 Calipso "Combi" and Tiller & Rowe "Growing Table-Mini Greenhouse and Raised Garden Bed" products because they can overheat and pose a fire hazard that may result in property damage and injury. The firm received 10 reports of overheating, including one injury report.

    Product
    Calipso "Combi" and Tiller & Rowe "Growing Table-Mini Greenhouse and Raised Garden Bed"
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1033-2024·2024-02-14

    BD BBL Sensi Disc Meropenem testing discs recalled for accuracy failures

    Becton Dickinson is recalling BD BBL Sensi Disc Meropenem antibiotic susceptibility testing discs due to accuracy and quality control failures that may cause delayed or incorrect diagnostic results.

    Product
    BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 and 231704¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1036-2024·2024-02-14

    BD BBL Sensi Disc Ofloxacin discs recalled for antibiotic testing accuracy failures

    Becton Dickinson is recalling BD BBL Sensi Disc Ofloxacin testing discs due to potential accuracy failures. These failures could lead to delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1028-2024·2024-02-14

    BD BBL clarithromycin susceptibility test discs recalled for accuracy and quality failures

    Becton Dickinson recalls BD BBL Sensi Disc Clarithromycin-15 ug susceptibility testing discs due to accuracy and reproducibility failures that may produce inaccurate test results in clinical laboratories.

    Product
    BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231678¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1008-2024·2024-02-14

    Brasseler dental burs recalled due to defective latching mechanism

    Brasseler USA recalls 440 dental burs due to right angle latch specification failure that prevents proper latching in dental handpieces.

    Product
    Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0993-2024·2024-02-14

    FilmArray Pneumonia Panel Plus Test Kits Recalled for False Positive Results

    BioFire Diagnostics is recalling FilmArray Pneumonia Panel Plus diagnostic test kits due to a potential for false positive results. These inaccurate results could lead to incorrect pneumonia diagnoses.

    Product
    FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
    Category
    Medical Device
    Distribution
    Distributed nationwide