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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6926–6950 of 13666

  • HighFDA (Devices)·Z-1361-2024·2024-04-03

    Thermalon Sinus Compress Recalled for Potential Mold and Mildew

    Bruder Healthcare Company is recalling 1,416 units of Thermalon Sinus Compress (Item Number 24332) due to potential mold and mildew growth from excessive moisture exposure. Affected lot numbers are M053160 and M053570.

    Product
    Thermalon Sinus Compress, Item Number 24332
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1363-2024·2024-04-03

    Thermalon Neck Wrap recalled due to potential mold and mildew growth

    Bruder Healthcare Company is recalling Thermalon Neck Wrap (Item Number 24322) from certain lots due to potential mold and mildew growth from excessive moisture exposure. Consumers should discontinue use and contact the manufacturer.

    Product
    Thermalon Neck Wrap, Item Number 24322
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1376-2024·2024-04-03

    Access Substrate Reagent Bottles Recalled for Missing Product Labels

    Beckman Coulter is recalling Access Substrate reagent bottles (REF 81906) due to missing product labels on certain manufacturing lots. While the missing labels may delay patient test result reporting, no incorrect results have been reported.

    Product
    Access Substrate, REF 81906, For use with the Access Immunoassay Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1387-2024·2024-04-03

    CareEvent Event Management System notification failure on locked iOS devices

    The CareEvent Event Management System's Care Assist mobile application fails to play custom ringtones when iOS device screens are locked with a passcode. This may result in missed alerts or notifications.

    Product
    CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1364-2024·2024-04-03

    Thermalon Heating Pads Recalled for Potential Mold and Mildew Growth

    Bruder Healthcare recalls Thermalon Heating Pad model 24002 due to potential mold and mildew growth from moisture exposure. Affected units were distributed nationwide in the US and to Canada.

    Product
    Thermalon Heating Pad, Item Number 24002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1386-2024·2024-04-03

    Philips Patient Information Center Custom Ringtones Fail When Screen Locked

    Philips Patient Information Center iX running software version 4.X may not play custom ringtones when iOS screens are locked with a passcode. Approximately 257,183 units have been distributed worldwide. No injuries have been reported.

    Product
    Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1274-2024·2024-03-27

    Smiths Medical Pneupac paraPAC plus 310 ventilators recalled for malfunction

    Smiths Medical is recalling paraPAC plus 310 ventilators that may malfunction by delivering continuous gas flow instead of cycling breaths. The defect affects 10,140 units distributed worldwide and prevents proper ventilation.

    Product
    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1301-2024·2024-03-27

    HeartMate 3 Left Ventricular Assist System recalled for outflow graft obstruction

    The FDA is recalling the HeartMate 3 Left Ventricular Assist System due to observed outflow graft deformation that can obstruct blood flow. Patients with implanted devices should contact their healthcare provider.

    Product
    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1267-2024·2024-03-27

    ARROW QuickFlash Radial Artery Catheters Recalled for Defective Component

    ARROW International is recalling 1,160,470 QuickFlash radial artery catheterization devices due to a defective guidewire handle that can cause arterial vasospasm and vessel injury.

    Product
    ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FMH1; c) REF ASK-04220-HHC; d) REF ASK-04220-KSP; e) REF ASK-04220-PSU; f) REF ASK-04220-UCL1; g) REF ASK-04500-AH; h) REF ASK-04500-HF-S; i) R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1275-2024·2024-03-27

    Smiths Medical Pneupac Plus 300 Ventilator Cycling Malfunction

    Smiths Medical Pneupac Plus 300 ventilators may intermittently deliver continuous airflow instead of cycling breaths as designed. This malfunction affects 2,902 units distributed worldwide.

    Product
    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1300-2024·2024-03-27

    FDA Recalls HeartMate II Left Ventricular Assist Systems for Graft Obstruction

    Thoratec Corp. recalls HeartMate II left ventricular assist system kits due to outflow graft deformation that could obstruct blood flow. The FDA has classified this as a Class I recall affecting 2,240 units distributed worldwide.

    Product
    HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate II LVAS Implant Kit, OUS REF 106016 Update (February 14, 2024) HeartMate II Left Ventricular As
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1321-2024·2024-03-27

    Preat Nobel RP Titanium Abutment Blank Recalled for Manufacturing Defect

    Preat Corp is recalling 561 units of RP Titanium Abutment Blanks due to a manufacturing defect where the screw seat location may be too high, resulting in shortened screw engagement into the implant.

    Product
    Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1331-2024·2024-03-27

    Directional Laser Probe Recalled for Fiber Extension and Direction Difficulties

    D.O.R.C. Dutch Ophthalmic Research Center is recalling Directional Laser Probes for ophthalmic surgery due to difficulties extending, retracting, and directing the laser fiber. The recall affects 84 units distributed nationwide.

    Product
    Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1318-2024·2024-03-27

    TMINI Knee Instrument Array Guide May Bind During Surgical Drilling

    A precision component in Think Surgical's TMINI robotic knee system may bind due to insufficient clearance. The binding could occur during surgical drilling.

    Product
    Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1329-2024·2024-03-27

    Hip Traction Boot Assembly Defect Could Cause Device Detachment

    Baxter Healthcare is recalling HDS Traction Boot II units due to incorrect assembly. The boot key socket locking ridge faces upward, preventing proper attachment to the traction system.

    Product
    HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's foot for hip surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1308-2024·2024-03-27

    Curaplex Nasal Intubation Kit with incompatible tube holder recalled

    Sarnova HC is recalling the Curaplex Nasal Intubation Kit because the endotracheal tube holder is incompatible with nasal intubation, preventing practitioners from securing the tube. The recall affects 550 units distributed nationwide.

    Product
    Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023070S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1322-2024·2024-03-27

    Dental Implant Impression Coping Recalled for Manufacturing Defect

    Thommen Medical AG is recalling impression coping units because the internal canal depth was not manufactured according to specifications, preventing firm connection to the dental implant. The product was distributed in Ohio and Kentucky.

    Product
    impression coping, repositionable, short, screw-retained, PF 4.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1343-2024·2024-03-27

    Vascular Guidewire Introducer Sheath Recalled for Internal Hub Defect

    Angiodynamics recalls 130 MINI STICK MAX guidewire introducers due to hub voids that may prevent guidewire passage during vascular procedures. No injuries reported.

    Product
    MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-765
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1304-2024·2024-03-27

    Siemens DCA HbA1c Reagent Kit Recalled for Inaccurate Test Results

    Siemens is recalling its DCA HbA1c Reagent Kit because the device displays falsely elevated readings without alerting the user. This could lead to incorrect patient management of glucose levels.

    Product
    DCA Systems HbA1c Reagent Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1314-2024·2024-03-27

    Abbott Point of Care Control Device Recalled Due to Temperature Storage Failure

    Abbott's i-STAT Level 1 control device is recalled because a refrigerator temperature excursion on January 8, 2024, could cause incorrect or delayed test results. The walk-in storage unit failed, causing temperatures to fall below the required range of 35.6-46.4°F.

    Product
    Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1310-2024·2024-03-27

    ECMO heat exchanger module recalled due to water path restriction

    Mc3 Inc is recalling 188 Nautilus Smart ECMO modules nationwide due to potential water path restrictions in the heat exchanger that may cause inadequate heat transfer and risk of hypothermia during use.

    Product
    NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 48135E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1333-2024·2024-03-27

    Directional Laser Probe Recalled for Fiber Extension and Direction Failure

    D.O.R.C. recalls 78 directional laser probes with Alcon/Lumenis connectors due to difficulties extending, retracting, or directing the laser fiber. The Class II recall affects units distributed across multiple U.S. states and Puerto Rico.

    Product
    Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1312-2024·2024-03-27

    Pregnancy Test Control Set Recalled for Temperature Excursion Risk

    McKesson recalls Abbott Rapid Dx pregnancy test control sets due to a refrigerator temperature excursion that could cause inaccurate or delayed test results.

    Product
    Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1340-2024·2024-03-27

    Vascular Guidewire Introducer Recalled Due to Internal Hub Defect

    A vascular guidewire introducer is recalled because internal voids in the hub may prevent proper guidewire passage, potentially delaying surgical procedures.

    Product
    MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-758
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1303-2024·2024-03-27

    Access Total T4 thyroxine assay recalled for test imprecision

    Beckman Coulter recalls Access Total T4 thyroxine assay due to imprecision that may cause erroneous or delayed diagnostic results.

    Product
    Access Total T4, REF 33800, IVD, thyroxine reagent assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide