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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8876–8900 of 13731

  • 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-2117-2023·2023-07-19

    Medtronic spinal implant recall due to out-of-specification device dimensions

    Medtronic Catalyft LS Expandable Interbody System spinal implants are being recalled due to out-of-specification device dimensions that may affect proper placement and spinal support.

    Product
    Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-2129-2023·2023-07-19

    Ortho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Calibrator Kit 20 due to measurement bias affecting laboratory results for immunoglobulin and complement protein testing. Falsely elevated or reduced values could be reported.

    Product
    VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C
    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-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-2137-2023·2023-07-19

    Medline Non-Sterile PVP Surgical Solution Kits Mislabeled as Sterile

    Medline is recalling 4,500 surgical kits because the non-sterile PVP solution inside was mislabeled as sterile. Using the mislabeled product in sterile surgical procedures could introduce non-sterile materials into surgical fields.

    Product
    MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I; d) BSHR TOTAL KNEE-LF, Model Number DYNJ24525K; e) BSHR TOTAL HIP-LF, Model Number DYNJ24
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2126-2023·2023-07-19

    GE Healthcare Vivid S60N ultrasound devices experience boot-up delays

    GE Healthcare Vivid S60N ultrasound systems may fail to boot in a timely manner. This can delay device availability during time-critical emergency situations.

    Product
    GE Healthcare Vivid S60N, 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-2130-2023·2023-07-19

    Ambulance stretcher base leg assembly may bend causing tip and unstable motion

    Stryker Power-PRO 2 ambulance cots may develop bent base leg assemblies, risking cot tips, unstable motion, and operational difficulties. Approximately 1,980 units were recalled.

    Product
    Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is designed to support and transport a maximum weight of 700 lb (318 kg). Model Number: 6507
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2023·2023-07-19

    Surgical chest support device recalled for potential cracking at attachment

    Baxter Healthcare recalls 1,010 Allen Advance Chest Support devices due to potential cracking where the support attaches to operating room table rails. No injuries reported.

    Product
    Allen Advance Chest Support with Pad
    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-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
  • 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-2121-2023·2023-07-19

    Medtronic Catalyft LS Spinal Implant Recall Due to Out-of-Specification Geometry

    Medtronic recalls 10 units of Catalyft LS spinal implants due to potential out-of-specification device geometries. The affected implants may not properly support or accommodate patient anatomy during lumbar fusion surgery.

    Product
    Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2143-2023·2023-07-19

    HeartSine Defibrillator Battery and Electrode Cartridges May Fail to Function

    HeartSine battery and electrode cartridges for defibrillators may contain depleted battery cells, rendering them inoperable and preventing cardiac rhythm analysis or therapy delivery. Approximately 30,022 units are affected worldwide.

    Product
    HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P
    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-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
  • 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-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-2029-2023·2023-07-12

    TruSignal Wrap Sensor Oximeter Recalled for Defibrillation Failure

    GE Healthcare is recalling 5,039 TruSignal Wrap Sensor oximeters due to potential defibrillation energy loss, electrical shock risk, and inaccurate measurements. No illnesses have been reported.

    Product
    TruSignal Wrap Sensor, REF TS-W-D; 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-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-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