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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8076–8100 of 13652

  • HighFDA (Devices)·Z-0203-2024·2023-11-08

    Coapt Dome Electrode Gen2 System Recalled for Burn Risk

    Coapt LLC is recalling the Dome Electrode Gen2 system due to potential burns or blistering from exposure to sunlight, warm temperatures exceeding 12 hours, or battery damage.

    Product
    Coapt Dome Electrode, Gen2 system, cutaneous electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0198-2024·2023-11-08

    RX Daytona Plus clinical chemistry analyzer may report incorrect test results

    The RX Daytona Plus clinical chemistry analyzer may report incorrect results when samples fall outside normal range and the automatic rerun feature malfunctions. Randox Laboratories is recalling 5 units distributed nationwide.

    Product
    RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0211-2024·2023-11-08

    Cosmedent FlexiCup Polishing System Recalled for Crumbling Elastomer Cup

    Cosmedent is recalling the FlexiCup Composite Finishing & Polishing System due to reports that the elastomer cup material is crumbling. Approximately 7,400 packs distributed worldwide are affected.

    Product
    Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0169-2024·2023-11-08

    McGrath Mac 2 Disposable Laryngoscope Blades Recalled for Ineffective Anti-Fog Coating

    Covidien recalled 42,367 McGrath Mac 2 disposable laryngoscope blades due to an ineffective anti-fog agent that may cause screen condensation and visual obstruction during intubation procedures.

    Product
    McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0214-2024·2023-11-08

    Unity Total Knee System Inserts May Be Mislabeled With Wrong Size

    Corin Ltd is recalling Unity Total Knee System inserts due to a labeling mix-up between batches 529803 and 532405, potentially affecting size 6 and size 7 designations.

    Product
    Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0205-2024·2023-11-08

    Pediatric Tracheostomy Tube Recalled Due to Incorrect Box Expiration Date Label

    Smiths Medical recalls a pediatric tracheostomy tube because the outer box shows an incorrect expiration date (3/17/2021) while the actual product has the correct date (3/17/2026). The discrepancy could cause confusion about product validity.

    Product
    Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0204-2024·2023-11-08

    Coapt ControlSeal Electrode Recalled Due to Burn and Blistering Risk

    Coapt LLC is recalling 109 ControlSeal Electrodes due to risk of minor burns or blistering if exposed to direct sunlight or warm temperatures exceeding 12 hours, or if the battery is damaged.

    Product
    Coapt ControlSeal Electrode, cutaneous EMG Electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0217-2024·2023-11-08

    DBS Lead Device Recall: Use By Date Label Discrepancy

    Medtronic is recalling a small number of LEAD 3387S-40 deep brain stimulation devices due to discrepancies in the Use By Date printed on the outer package versus the individual product label.

    Product
    LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0210-2024·2023-11-08

    Endoscopic Vessel Harvesting System Recalled for Incorrect Outer Box Packaging

    Vasoview 6 Pro endoscopic vessel harvesting systems were packaged in incorrect outer boxes displaying artwork for a different device (Vasoview Hemopro 2). The inner labels and product documentation are correct.

    Product
    Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box artwork for Vasoview Hemopro 2 (HP2).
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0209-2024·2023-11-08

    Abbott NT2000iX radiofrequency generator serviced with out-of-tolerance tool

    Abbott is recalling 34 NT2000iX radiofrequency generators that were serviced using an out-of-tolerance calibration tool, which may have provided inaccurate measurement results for capacitance failures.

    Product
    Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0212-2024·2023-11-08

    Hillrom Progressa+ Hospital Beds Recalled for Static Electricity Risk

    Hillrom Progressa+ hospital beds (499 units) are being recalled due to potential static electricity buildup that could cause mild shock to operators during transport. The affected units were distributed nationwide.

    Product
    HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A000054, P7501A000055, P7501A001851, P7501A001972, P7501A001973, and P7501A001974
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0197-2024·2023-11-08

    Quest Medical Recalls Q2 Multiport Intravenous Extension Sets

    Quest Medical is recalling 17,700 Q2 Multiport Extension Sets distributed in the US and Canada. The nature of the defect is not detailed in available source documentation.

    Product
    Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV manifold and integrated back-check valves, pre-attached needleless injection sites, drip chamber and roller clamps.
    Category
    Medical Device
    Distribution
    19 states
  • CriticalFDA (Devices)·Z-0149-2024·2023-11-01

    Monoject 35 mL Syringe Recalled for Pump Incompatibility Issues

    Cardinal Health is recalling 1,097,048 Monoject 35 mL syringes due to demonstrated compatibility and recognition issues with infusion pumps. The affected units were distributed nationwide.

    Product
    Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0124-2024·2023-11-01

    Infusomat Large Volume Pump False Occlusion Alarm May Interrupt Medication

    B. Braun's Infusomat Large Volume Pump battery pack may sound a false occlusion alarm, causing the device to stop pumping. This interruption of high-risk medications can lead to hemodynamic instability and serious medical consequences.

    Product
    8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0111-2024·2023-11-01

    ResMed Astral ventilators recalled for power loss and failed alarms

    ResMed recalls Astral ventilators due to a battery fault that can cause sudden power loss. The backup alarm system may fail to alert users due to supercapacitor degradation.

    Product
    Astral 100 and Astral 150 ventilators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0147-2024·2023-11-01

    Monoject 12 mL Syringes Recalled for Infusion Pump Compatibility Issues

    Cardinal Health recalls 3 million Monoject 12 mL Luer-Lock syringes due to demonstrated compatibility issues with syringe infusion pumps that may affect medication delivery.

    Product
    Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0150-2024·2023-11-01

    Monoject 60 mL Syringes Recalled for Infusion Pump Compatibility Issues

    Cardinal Health is recalling 457,200 Monoject 60 mL Luer-Lock tip syringes due to demonstrated compatibility issues with certain infusion pump systems. The affected syringes may fail to function correctly with these pumps.

    Product
    Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0146-2024·2023-11-01

    Monoject 6 mL Syringes Recalled Due to Infusion Pump Incompatibility

    Cardinal Health is recalling Monoject 6 mL Luer-Lock syringes (approximately 3.9 million units) nationwide due to demonstrated recognition and compatibility issues with syringe infusion pumps.

    Product
    Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0145-2024·2023-11-01

    Monoject 1 mL Tuberculin Syringes Recalled for Infusion Pump Compatibility Issues

    Cardinal Health recalls approximately 3.1 million Monoject 1 mL Tuberculin Syringes due to demonstrated compatibility and recognition issues with syringe infusion pumps. Nationwide distribution affected.

    Product
    Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0123-2024·2023-11-01

    B. Braun Infusomat Large Volume Pump may stop delivering medication due to false alarm

    The Infusomat Large Volume Pump may incorrectly sound an occlusion alarm and stop delivering high-risk medications, potentially causing serious complications.

    Product
    8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0148-2024·2023-11-01

    Monoject 20 mL Syringes Recalled for Infusion Pump Compatibility Issues

    Cardinal Health is recalling 4.9 million Monoject 20 mL Luer-Lock syringes due to compatibility and recognition issues with infusion pumps. Affected lot numbers from 2022 and 2023 were distributed nationwide.

    Product
    Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0172-2024·2023-11-01

    Medical device components subjected to improper sterilization process and elevated exposure

    American Contract Systems is recalling LAVH surgical component kits because two components were subjected to improper sterilization temperatures and ethylene oxide exposure, potentially causing loss of functionality and higher chemical residuals.

    Product
    LAVH, REF BBLV21C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0047-2024·2023-11-01

    pH Test Strips Recalled for Unverified Manufacturing and Unknown Performance

    Universal Meditech Inc. is recalling HealthyWiser pH-Aware pH Test Strips because the manufacturer lacks documentation verifying manufacturing compliance and device performance. The company is ceasing operations and cannot fulfill post-market safety responsibilities.

    Product
    HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0060-2024·2023-11-01

    Diagnostic Test Strips Recalled for Manufacturing Conformance and Documentation Issues

    Universal Meditech Inc. is recalling diagnostic test strips due to Quality System violations and lack of manufacturing documentation. The company is closing and cannot provide post-market surveillance or support.

    Product
    DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0166-2024·2023-11-01

    Grafton Plus DBM Paste medical device recalled for packaging inspection failure

    Medtronic is recalling Grafton Plus DBM Paste due to a missed inspection step on the outer packaging. The outer Tyvek pouch may have non-conformances that could affect product integrity.

    Product
    Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
    Category
    Medical Device
    Distribution
    0 states