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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9426–9450 of 13731

  • HighFDA (Devices)·Z-1612-2023·2023-05-24

    Reprocessed DVT Compression Sleeves Recalled Due to Labeling and Packaging Errors

    Stryker Sustainability Solutions recalls reprocessed DVT compression sleeves that may be mislabeled or mispackaged. These prescription-only devices could be improperly identified or distributed due to packaging errors.

    Product
    REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1600-2023·2023-05-24

    Fisher Wallace Stimulator Models Recalled for Battery Overheat and Burn Risk

    Fisher Wallace Stimulator Models FW-100 and FW-200 are being recalled because incorrectly installed batteries may cause the device to overheat, potentially resulting in burns. The recall affects 43,489 devices distributed nationwide and globally.

    Product
    Fisher Wallace Stimulator Models FW-100 and FW-200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1596-2023·2023-05-24

    Urine Microscopy Analyzer Software Display Defect May Prevent Contamination Detection

    Beckman Coulter's iQ200 Series urine analyzers may fail to display a flag indicating prior samples, potentially preventing detection of sample contamination from carryover events.

    Product
    iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1580-2023·2023-05-24

    Breathing circuit swivel elbow recalled for inadequate sterilization instructions

    Smiths Medical is recalling DuraLife Swivel Elbow breathing circuit devices due to inadequate sterilization instructions. The device instructions lack cleaning methods, autoclave cycle duration, and reuse specifications.

    Product
    DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1585-2023·2023-05-24

    Philips Incisive CT system foot switch poses entrapment risk during unload

    The Philips Incisive CT system's foot switch may trap the operator's foot during the unload function, causing injury. The FDA has issued a Class II recall affecting 46 units worldwide.

    Product
    Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1603-2023·2023-05-24

    Immundiagnostik Lactoferrin ELISA Kit Recalled for Lacking FDA 510(k) Clearance

    IMMUNDIAGNOSTIK Inc. has recalled the IDK Lactoferrin ELISA diagnostic kit because it was marketed without the required FDA 510(k) premarket notification. No illnesses or injuries have been reported.

    Product
    Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1608-2023·2023-05-24

    Beckman Coulter Bicarbonate Reagent Recalled for Calibration Failure Risk

    Beckman Coulter is recalling Bicarbonate reagent (REF: OS6637) due to potential calibration failures. The reagent could produce decreased optical density readings affecting laboratory quality control.

    Product
    Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1588-2023·2023-05-24

    Philips diagnostic imaging systems recalled for missing FDA certification labels

    Philips is recalling 25 CombiDiagnost R90 diagnostic systems nationwide due to missing required FDA certification labels. Affected healthcare facilities should contact Philips for instructions.

    Product
    CombiDiagnost R90 R.1.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1583-2023·2023-05-24

    Greiner Bio-One Blood Collection Tubes Recalled for Labeling Error

    Greiner Bio-One blood collection tubes (VACUETTE TUBE 6ml K3EDTA) may be incorrectly labeled. The company is recalling 36,000 units distributed in Wisconsin and Georgia.

    Product
    greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1604-2023·2023-05-24

    Dental implant system recalled for incorrect package length labeling

    Hiossen Inc. is recalling 287 units of ET III Nano-HA dental implants due to incorrect package labeling stating implant length as 10mm when the actual length is 8.5mm. No illnesses or injuries have been reported.

    Product
    ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1610-2023·2023-05-24

    3M Attest Steam Chemical Integrators Recalled for Ink Leakage Risk

    3M is recalling 2.2 million Attest Steam Chemical Integrators (REF 1243B) due to an increased potential for ink leakage during sterilization cycles. No injuries have been reported.

    Product
    3M Attest Steam Chemical Integrators, REF 1243B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1587-2023·2023-05-24

    Diagnostic Imaging Systems Missing FDA Certification Label

    Philips North America is recalling 25 ProxiDiagnost N90 R.1.0 and CombiDiagnost R90 diagnostic imaging systems distributed nationwide because they are missing an FDA-required certification label.

    Product
    ProxiDiagnost N90 R.1.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1496-2023·2023-05-17

    Cordis Angioguard Emboli Capture Guidewire System Faces Separation Hazard

    Cordis's Angioguard RX/XP Emboli Capture Guidewire System is recalled due to potential separation of the delivery system and capture sheath, which could cause procedural delays, unplanned intervention, or stroke during use.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1490-2023·2023-05-17

    ANGIOGUARD RX/XP Emboli Capture Guidewire System May Separate During Procedures

    ANGIOGUARD RX/XP emboli capture guidewire systems may separate from their delivery sheaths during interventional procedures, potentially causing stroke. Cordis is recalling 56 units distributed worldwide.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1491-2023·2023-05-17

    Emboli Capture Guidewire System recalled due to potential device separation

    Cordis US Corp is recalling the ANGIOGUARD RX/XP Emboli Capture Guidewire System (1,087 units worldwide) due to potential separation of the delivery system and capture sheath, which could lead to stroke.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1486-2023·2023-05-17

    Emboli Capture Guidewire System Recalled Due to Potential Component Separation

    Cordis US Corp recalls 54 units of the ANGIOGUARD RX/XP Emboli Capture Guidewire System due to potential separation of device components. This could delay procedures or result in unplanned intervention, including possible stroke.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1483-2023·2023-05-17

    ANGIOGUARD RX / XP Emboli Capture Guidewire System separation during procedures

    The ANGIOGUARD RX / XP emboli capture guidewire system may separate from its delivery sheath during medical procedures, potentially leading to stroke or complications requiring emergency intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1489-2023·2023-05-17

    Emboli Capture Guidewire System recalls risk of device separation during procedures

    Cordis is recalling an emboli capture guidewire system due to potential separation of components during medical procedures. The separation could cause procedural delays, unplanned interventions, or stroke.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1428-2023·2023-05-17

    Cook Blue Rhino G2 Tracheostomy Introducer Trays Recalled for Connection Defect

    Cook Incorporated is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Trays because the device connectors are not making secure connections with 15mm caps and other circuit components, resulting in unsecure connections.

    Product
    Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720), C-PTISYJ-100-HC-G-NA-FLEX8.5 (G57721), C-PTISY-100-HC-G-NA-FLEX8.5 (G57717), C-PTISY-100-HC-G-NA-FLEX7.5 (G57716)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1494-2023·2023-05-17

    Emboli Capture Guidewire System recalled for component separation risk

    The ANGIOGUARD RX/XP Emboli Capture Guidewire System is being recalled because the delivery system and capture sheath may separate during procedures, potentially causing stroke or requiring emergency surgical intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1492-2023·2023-05-17

    ANGIOGUARD Emboli Capture Guidewire System Recalled Due to Device Separation

    The FDA has recalled the ANGIOGUARD RX/XP Emboli Capture Guidewire System because the delivery system and capture sheath could separate during use, potentially causing stroke or requiring emergency surgery.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1488-2023·2023-05-17

    FDA Class I Guidewire System Recalled for Device Separation Risk

    Cordis US Corp is recalling the ANGIOGUARD RX / XP Emboli Capture Guidewire System because the device may separate during procedures, risking stroke or requiring emergency intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1427-2023·2023-05-17

    Blue Rhino G2 Tracheostomy Introducer Sets Recalled for Unsecure Connections

    Cook Incorporated is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Sets due to unsecure connections with 15mm caps and circuit components that may disconnect during medical procedures.

    Product
    Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PTIS-100-HC-G-NA-FLEX8.5 (G57692)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1485-2023·2023-05-17

    ANGIOGUARD RX/XP Guidewire System May Separate During Medical Procedures

    The ANGIOGUARD RX/XP Emboli Capture Guidewire System may separate during medical procedures, potentially delaying treatment or requiring unplanned intervention. The recall affects 471 units distributed worldwide.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC
    Category
    Medical Device
    Distribution
    0 states