The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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10626–10650 of 13816

  • ModerateFDA (Devices)·Z-0650-2023·2022-12-21

    Medical Device Shoulder Pack Recall Initiated by Manufacturer

    DeRoyal Industries initiated a voluntary recall of 32 kits of its Shoulder Pack medical device distributed across 23 U.S. states. The specific reason for the recall was not provided in the source documentation.

    Product
    DeRoyal SHOULDER PACK, REF 89-9449.12
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0330-2023·2022-12-14

    Sensititre Medical Device Recall: False Antibiotic Susceptibility Test Results

    Remel Inc. is recalling Sensititre HPB1 diagnostic plates that may produce false susceptible results for specific bacteria when tested with seven antibiotics. This could lead to inaccurate susceptibility information affecting clinical treatment decisions.

    Product
    Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0334-2023·2022-12-14

    Sensititre STP6F diagnostic plates may report false antibiotic susceptibility results

    Remel's Sensititre STP6F diagnostic plates may produce false susceptible results for Gram-negative bacteria when tested with certain antibiotics, potentially leading to inappropriate treatment decisions.

    Product
    Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0337-2023·2022-12-14

    Liquid Oxygen System Devices Recalled Due to Weld Quality Issues

    Caire Inc. is recalling 70 CAIRE Liberator 45 liquid oxygen systems due to inconsistencies in weld penetration on the inner bottle's longitudinal weld seam discovered during an audit.

    Product
    CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0328-2023·2022-12-14

    Medical Device Recall: Sensititre GN6F May Report False Antibiotic Susceptibility Results

    The FDA recalled Sensititre GN6F Gram Negative antimicrobial susceptibility test plates (2,471 units) because they may report false results indicating bacteria are susceptible to certain antibiotics when they are actually resistant.

    Product
    Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0323-2023·2022-12-14

    Dewei DNA/RNA Preservation Kits recalled for lack of FDA authorization

    Dewei DNA/RNA Preservation Kits (catalog DW-80005-1B) were distributed in the U.S. without FDA authorization or clearance. Approximately 1,348,000 units were distributed to California, Florida, Kentucky, and Michigan.

    Product
    Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0338-2023·2022-12-14

    FDA Class I Recall: CAIRE Liberator 30 Liquid Oxygen System Units

    Caire, Inc. is recalling five CAIRE Liberator 30 liquid oxygen system units due to weld defects on the inner bottle that could lead to device failure and loss of oxygen supply to dependent patients.

    Product
    CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0332-2023·2022-12-14

    FDA Class I Recall: Thermo Sensititre Gram Negative Diagnostic Test Inaccuracy

    Thermo Scientific Sensititre CMC7AFLF Gram Negative diagnostic tests may produce false susceptible results for certain bacteria, potentially leading to ineffective antibiotic treatment decisions. The FDA has classified this as a Class I recall.

    Product
    Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0335-2023·2022-12-14

    Medical Device Recall: Sensititre Test Produces False Antibiotic Susceptibility Results

    Remel Inc. is recalling a diagnostic test that may incorrectly report antibiotic susceptibility in certain Gram-negative bacteria. False results could lead to inappropriate antibiotic treatment.

    Product
    Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0327-2023·2022-12-14

    Thermo Sensititre diagnostic plate recalled for false susceptibility results

    Sensititre diagnostic plates may give false antibiotic susceptibility results for certain bacteria species, potentially affecting treatment decisions. The FDA issued a Class I recall for approximately 1,917 units distributed nationwide.

    Product
    Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0339-2023·2022-12-14

    CAIRE Liberator 20 Liquid Oxygen System Recalled for Weld Defects

    Caire, Inc. is recalling CAIRE Liberator 20 liquid oxygen system units due to weld penetration inconsistencies discovered during an FDA audit. The manufacturing defect affects 3 units.

    Product
    CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0336-2023·2022-12-14

    Caire Liberator 45 Liquid Oxygen System Recalled for Weld Defects

    Caire, Inc. is recalling 10 CAIRE Liberator 45 liquid oxygen system units due to inconsistencies in weld penetration on the inner bottle discovered during an FDA audit.

    Product
    CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0331-2023·2022-12-14

    Medical Diagnostic Plate Recalled for False Antibiotic Susceptibility Test Results

    Remel Inc is recalling 588 units of the Sensititre Gram Negative IVD AST diagnostic plate due to false susceptible test results for certain bacteria when tested with specific antibiotics. The defect could lead to incorrect treatment decisions.

    Product
    Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0329-2023·2022-12-14

    Sensititre GN7F Antibiotic Test Plates Recalled for Inaccurate Susceptibility Results

    Remel Inc. recalled 8,073 units of Sensititre GN7F antibiotic susceptibility test plates after discovering they may report false results for certain bacteria, potentially leading to incorrect antibiotic treatment decisions.

    Product
    Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0378-2023·2022-12-14

    Bipolar Forceps Recalled for Missing Power Supply and Cleaning Instructions

    Carefusion 2200 Inc is recalling 203 units of V. Mueller SEMKIN Bipolar Forceps due to incomplete Instructions for Use. The IFU is missing critical content related to power supply interface and cleaning/maintenance procedures.

    Product
    Carefusion V. Mueller" SEMKIN BIPOLAR FORCEPS WITH STOP, 0.7MM TIP OVERALL LENGTH 5-1/2" (140MM), REF F-1040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0376-2023·2022-12-14

    Surgical Bipolar Forceps Recall: Incomplete Instructions for Use

    Carefusion is recalling 218 units of surgical bipolar forceps due to incomplete product instructions. The Instructions For Use is missing information about power supply interface and cleaning/maintenance procedures.

    Product
    Carefusion V. Mueller HARDY BAYONET BIPOLAR FORCEPS WITH STOP, 0.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-1030
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0423-2023·2022-12-14

    Omnipod 5 Controller charging port melting poses minor burn risk

    Insulet is recalling Omnipod 5 Controllers where the charging port and cable may melt or deform from excessive heat, potentially causing minor burns if touched and preventing the device from charging.

    Product
    Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US PT-000429: Cable, Charging, Omnipod 5, Horizon PDM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0358-2023·2022-12-14

    Dover Urinary Catheter Drainage Tray Recall Due to Blockage Risk

    Cardinal Health is recalling Dover Closed Urethral Tray urinary drainage systems due to potential blockage of the drainage bag inlet port, which may prevent proper bladder emptying and increase the risk of urinary retention.

    Product
    Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended for urinary drainage from the bladder of a patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0382-2023·2022-12-14

    Surgical Bipolar Forceps Recalled for Missing Instructions

    Carefusion is recalling the V. Mueller Bipolar Forceps Insulated due to missing instructions for power supply interface and cleaning/maintenance procedures.

    Product
    Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LENGTH 7" (180MM), REF F-1112
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0372-2023·2022-12-14

    Shoulder Surgical Navigation System Warning for Bone Stability

    A warning has been added to the NextAR Shoulder surgical navigation platform advising verification of adequate coracoid bone stability. Inadequate stability could lead to bone fracture during reverse shoulder surgery.

    Product
    NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0401-2023·2022-12-14

    Bipolar Forceps Recall: Missing Device Use and Maintenance Instructions

    CareFusion bipolar forceps recalled due to incomplete Instructions for Use. Missing documentation covers power supply interface and cleaning/maintenance procedures.

    Product
    CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5016
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0368-2023·2022-12-14

    Treadmill safety mechanism may fail to stop during fall

    Full Vision Inc. Trackmaster treadmills (Model #317-07926GE) may fail to stop during a fall if the magnetic safety mechanism malfunctions. 69 units are affected.

    Product
    FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST1 110V, Model #317-07926GE
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0415-2023·2022-12-14

    CareFusion Bipolar Forceps Recalled Due to Incomplete Instructions

    CareFusion recalls 142 units of bipolar surgical forceps due to incomplete Instructions for Use lacking power supply interface and maintenance guidance found in the manufacturer's version.

    Product
    CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.0MM TIP, STR, MED, INSULATED OVERALL LENGTH 8-3/4" (225MM), REF F-5303
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0357-2023·2022-12-14

    Dover Urethral Catheter Drainage System Recall for Potential Port Blockage

    Cardinal Health is recalling Dover closed urethral catheter trays because the drainage bag port may become occluded, preventing urine from draining properly and increasing the risk of urinary retention.

    Product
    Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for urinary drainage from the bladder of a patient
    Category
    Medical Device
    Distribution
    Distributed nationwide