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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9601–9625 of 39932

  • HighFDA (Devices)·Z-2120-2023·2023-07-19

    Medtronic Catalyft LS Spinal Implants Recalled for Out-of-Specification Geometry

    Medtronic is recalling 11 units of its Catalyft LS Expandable Interbody System spinal implants due to potential out-of-specification dimensions that could affect surgical fit and stability.

    Product
    Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2108-2023·2023-07-19

    Osteomed AutoDrive Screws Recalled for Undersized Screw Head

    Osteomed recalls orthopedic AutoDrive screws used in osteotomy procedures due to undersized screw heads that could pass through the mounting plate hole, potentially affecting surgical fixation.

    Product
    REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2123-2023·2023-07-19

    Medtronic Catalyft LS Spinal Implant Recalled for Out-of-Specification Geometry

    Medtronic recalls Catalyft LS spinal implants due to potential out-of-specification dimensions. The affected devices may not properly fit or function as intended during spine fusion surgery.

    Product
    Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2119-2023·2023-07-19

    Medtronic Catalyft LS Spinal Implants Recalled for Out-of-Specification Dimensions

    Medtronic recalls 25 units of Catalyft LS spinal implants (lot numbers NM21J039, NM21M026) due to out-of-specification device dimensions that may affect surgical fit and function.

    Product
    Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2138-2023·2023-07-19

    Medical Blood Cell Diluent Recalled for Out-of-Specification Parameters

    Beckman Coulter is recalling specific lots of COULTER DxH Diluent due to out-of-specification conductivity, osmolality, and pH. The diluent may produce inaccurate blood cell test results.

    Product
    COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2125-2023·2023-07-19

    GE Healthcare Vivid S70 ultrasound systems fail to boot timely

    GE Healthcare Vivid S70 ultrasound devices may experience delayed startup. This can reduce equipment availability during time-critical emergency situations.

    Product
    GE Healthcare Vivid S70, ultrasound device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2131-2023·2023-07-19

    Medline PVP solution mislabeled as sterile when non-sterile

    Medline Industries is recalling batches of non-sterile PVP solution that were incorrectly labeled as sterile, creating risk of inadvertent use in sterile medical settings.

    Product
    MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2133-2023·2023-07-19

    Medline Non-Sterile PVP Solution Kits Mislabeled as Sterile

    Medline is recalling Total Knee Theda surgical kits where the non-sterile PVP solution was mislabeled as sterile. Healthcare providers should immediately stop using the recalled kits and contact Medline.

    Product
    MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2134-2023·2023-07-19

    Medline Non-Sterile PVP Solution Mislabeled as Sterile

    Medline Industries is recalling 128 units of non-sterile PVP solution incorrectly labeled as sterile. Using a non-sterile product in sterile contexts could create infection risk.

    Product
    MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2124-2023·2023-07-19

    Ultrasound Device Boot Failure May Delay Emergency Availability

    Certain GE HealthCare Vivid S60 ultrasound systems may not boot up in a timely fashion, potentially delaying device availability in time-critical emergency situations.

    Product
    GE Healthcare Vivid S60, ultrasound device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2118-2023·2023-07-19

    Medtronic Catalyft LS spinal implant recalled for out-of-specification device dimensions

    Medtronic is recalling eight units of Catalyft LS Expandable Interbody System spinal implants due to potential out-of-specification device dimensions that could affect surgical fitting and spinal stability.

    Product
    Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2122-2023·2023-07-19

    Medtronic Catalyft LS Spinal Implant Recall for Out-of-Spec Geometry

    Medtronic is recalling Catalyft LS spinal implants due to potential out-of-specification device geometries that may not properly accommodate patient anatomy.

    Product
    Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2127-2023·2023-07-19

    GE Vivid S70N Ultrasound Device Boot Failure Recall

    GE Healthcare recalls certain Vivid S70N ultrasound devices that may not boot promptly, potentially delaying availability in time-critical emergencies.

    Product
    GE Healthcare Vivid S70N, ultrasound device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2107-2023·2023-07-19

    Orthopedic Screw Recall Due to Undersized Head in Surgical Device

    Osteomed is recalling orthopedic screws with undersized heads that may pass through bone plates. Affected lot numbers were distributed nationwide in the US and Singapore.

    Product
    REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2135-2023·2023-07-19

    Medline Non-Sterile PVP Solution Incorrectly Labeled as Sterile

    Medline is recalling Non-Sterile PVP Solution Hystero Pack kits due to mislabeling: affected lots labeled as 'Sterile' when actually 'Non-Sterile'. Using non-sterile solution in sterile gynecological procedures creates infection risk.

    Product
    MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2132-2023·2023-07-19

    Medline Non-Sterile PVP Solution Mislabeled as Sterile Product

    Medline Industries recalled 15 units of non-sterile PVP solution in EAR CDS kits that were mislabeled as 'Sterile PVP SLN' instead of 'Non-Sterile PVP Solution, Sterile Packaging.' The mislabeling could result in inappropriate use in sterile medical applications.

    Product
    MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number CDS980089O
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2034-2023·2023-07-12

    Medical Oximeter Sensor Recalled Due to Defibrillation Energy and Voltage Hazards

    GE Healthcare is recalling 237 TruSignal Integrated Ear Sensors worldwide due to potential failures in defibrillation energy delivery, unintended voltage contact, and measurement inaccuracy.

    Product
    TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2031-2023·2023-07-12

    Ear oximeter sensor recalled for defibrillation and voltage safety concerns

    GE Healthcare is recalling 512 TruSignal ear oximeter sensors worldwide due to potential defibrillation energy loss, unintended voltage exposure, and measurement inaccuracy risks.

    Product
    TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2032-2023·2023-07-12

    GE TruSignal Ear Sensor recalled for defibrillation, voltage, and measurement risks

    GE Healthcare is recalling 2,707 TruSignal Integrated Ear Sensors (GTIN 00840682103428) worldwide due to potential reduced defibrillation energy delivery, unintended voltage exposure, and inaccurate measurements.

    Product
    TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2026-2023·2023-07-12

    TruSignal adult and pediatric ear oximeter sensors recalled for voltage hazards

    GE Healthcare's TruSignal Adult/Pediatric ear oximeter sensors are recalled worldwide due to potential reduction of defibrillation energy, risk of unintended electrical contact, and inaccurate oxygen measurement.

    Product
    TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2030-2023·2023-07-12

    GE TruSignal Ear Sensor oximeter recalled for electrical and measurement hazards

    GE Healthcare is recalling approximately 10,451 TruSignal Ear Sensor oximeters worldwide due to potential electrical hazards and inaccurate measurements that could affect patient safety.

    Product
    TruSignal Ear Sensor, REF TS-E-D; Oximeter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1974-2023·2023-07-12

    Quidel Triage Cardiac Panel Affected by Troponin Signal Reduction Defect

    Quidel Triage Cardiac Panel diagnostic kits are recalled due to a raw material defect causing approximately 30% troponin signal reduction. The defect won't be detected by quality controls, potentially resulting in missed or delayed heart attack diagnosis.

    Product
    Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045.
    Category
    Medical Device
    Distribution
    32 states
  • SevereFDA (Devices)·Z-2028-2023·2023-07-12

    FDA Recalls GE Healthcare Oximeter Sensors for Defibrillation and Electrical Hazards

    GE Healthcare is recalling 2,097 TruSignal Sensitive Skin Sensor oximeters worldwide due to risks of reduced defibrillation energy, unintended electrical contact, and inaccurate measurements.

    Product
    TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2027-2023·2023-07-12

    FDA Recalls TruSignal AllFit Oximeter Sensors Worldwide for Device Malfunction

    GE Healthcare is recalling 36,337 TruSignal AllFit Sensor oximeters worldwide due to potential defibrillation energy loss, voltage exposure, and measurement errors.

    Product
    TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2033-2023·2023-07-12

    GE TruSignal Ear Sensor Oximeter Recalled for Defibrillation Energy and Voltage Hazards

    GE Healthcare is recalling 708 TruSignal Integrated Ear Sensors (medical-grade pulse oximeters) due to potential defects that could reduce defibrillation energy, cause electrical shock, or produce inaccurate measurements.

    Product
    TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter
    Category
    Medical Device
    Distribution
    0 states