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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13026–13050 of 13802

  • HighFDA (Devices)·Z-2478-2021·2021-09-22

    Medtronic HVAD Pump Implants: Driveline Cover May Impede Connector Access

    Medtronic HVAD Pump Implant Kits may require increased force to remove the driveline cover after strain relief repair, potentially making controller exchanges difficult and risking further repair damage.

    Product
    Medtronic HVAD Pump Implant Kits
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2472-2021·2021-09-22

    Alinity ci-series System Control Module Software Performance Issues

    Abbott's Alinity ci-series analyzers with software version 3.2.3 and earlier have multiple issues that could display expired reagents as valid, fail to alert operators to errors, and produce incorrect test results.

    Product
    Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2479-2021·2021-09-22

    Bariatric ceiling-mounted lift spreader bar can disconnect from scale attachment

    Arjohuntleigh recalls 62 Maxi Sky 1000 and V10 bariatric ceiling lifts because the spreader bar can disconnect from the scale attachment. Users should immediately stop using affected units and contact the manufacturer.

    Product
    Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2459-2021·2021-09-22

    BD Alaris Infusion Pump Buerette Sets Needle-Free Connector Valve Issues

    BD Alaris Pump Infusion Buerette Sets with needle-free connector valves may experience flushing difficulties, flow issues, or occlusions that could delay therapy delivery. No illnesses or injuries have been reported.

    Product
    BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alaris Pump Infusion Buerette Set Ball Valve Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 10817920; BD Alaris Pump Infusion Bue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2464-2021·2021-09-22

    Needle-Free Burette Set Valves Recalled for Occlusion and Flow Issues

    BD ADD-ON Burette Set V/NV Needle-Free Valves may experience occlusions or flow issues that could delay therapy. CAREFUSION recalled 44,120 units with this defect.

    Product
    BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2452-2021·2021-09-22

    Cellex COVID-19 Antigen Test kits recalled for lacking FDA emergency use authorization

    Cellex is recalling approximately 44,821 units of its qSARS-CoV-2 Antigen Rapid Test due to lack of FDA emergency use authorization. The test was distributed nationwide in California, Florida, Texas, and Wisconsin.

    Product
    Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2475-2021·2021-09-22

    Philips Allura Xper Imaging System Overheating and Malfunction Recall

    Philips Allura Xper imaging systems may fail early when supplied with 480V, causing coil overheating and burning smell. When the system fails, X-ray imaging capability is reduced to emergency mode only.

    Product
    The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2474-2021·2021-09-22

    Philips Allura Xper X-ray imaging system failures at 480V power supply

    Four Philips Allura Xper X-ray imaging systems may fail prematurely when powered at 480V hospital mains, causing coil overheating and reduced imaging performance.

    Product
    The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2468-2021·2021-09-22

    BD Needle-Free Bag Access Valves Recalled for Flow Obstruction

    BD SmartSite needle-free valves may become obstructed, preventing proper fluid flow in medical infusions. The FDA recalls over 295,000 units due to risk of therapy delays.

    Product
    BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check Valve And Needle Free Valve, REF: 2309E-0006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2473-2021·2021-09-22

    McKesson Lap Sponges Recalled for Failed Sterilization Indicator

    Cypress Medical Products is recalling one case of McKesson Lap Sponges due to a failed sterilization indicator that did not change from red to blue, compromising verification of proper sterilization.

    Product
    McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2476-2021·2021-09-22

    Philips Azurion Imaging System Failure at 480V Hospital Power Supply

    Philips Azurion medical imaging devices may fail when powered by hospital electrical systems providing 480V. The failure reduces X-ray performance and may be preceded by a burning smell.

    Product
    The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2460-2021·2021-09-22

    BD needle-free connector valves recalled for flow obstruction risk

    BD needle-free connector valves and extension sets may experience flow obstruction and flushing difficulties, potentially delaying medical therapy. No adverse events have been reported.

    Product
    BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite Extension Set Needle-Free Valve, REF: 10010912; BD EXTENSION SET SMALLBORE TUBING DETACHABLE SmartSite VALVE, REF: 10010983; BD Gravity Burette Set 60 DP 4 VersaSafe PORTS 3 SmartSite VALVES BALL VALV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2453-2021·2021-09-22

    Configura Advance Mobility Chairs Recalled for Potential Backrest Detachment

    Accora Inc is recalling multiple Configura Advance Chair models due to a potential defect where the backrest may detach, creating a fall risk for users.

    Product
    Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std Backrest, Manual; Serial Numbers: 10001-SC1-20 to 10483-SC1-20; 10001-SC1-21 to 10224-SC1-21; 10231-SC1-21 to 10456-SC1-21; 10481-SC1-21 to 10570-SC1-21. Model Number: CHAIR-0-SC2-030; A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2457-2021·2021-09-22

    BD Syringe Set Needle-Free Connector Valves May Cause Therapy Delay

    BD Syringe Set needle-free connector valves may experience difficulty flushing, flow issues, or occlusions that could delay patient therapy. About 16,700 units have been distributed worldwide.

    Product
    BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798696; BD Syringe Set 20 DP MIC TBG CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798703;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2477-2021·2021-09-22

    Lyra Direct SARS-CoV-2 Assay Instructions Revised for False Negative Risk

    The Lyra Direct SARS-CoV-2 assay can produce false negatives on certain PCR machines when specimens have high viral loads. Revised instructions address this diagnostic failure risk affecting approximately 81,910 kits distributed worldwide.

    Product
    Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab speci
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2467-2021·2021-09-22

    BD SmartSite Needle-Free Connector Valves Recalled for Flow and Occlusion Issues

    CAREFUSION is recalling BD SmartSite needle-free connector valves due to difficulty flushing, flow issues, and occlusions that could delay therapy. Approximately 23.8 million units were distributed worldwide.

    Product
    BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free Valve, REF: 20021E7D; BD SmartSite Extension Set One Needle Free Valve Slip Luer, REF: 20037E7D; BD SmartSite Extension Set 3 Needle Free Valves, REF: 20038E7D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2466-2021·2021-09-22

    BD Alaris Infusion Pump Buerette Set Connector Valve Occlusion Issues

    BD Alaris needle-free connector valves in Buerette Sets may develop occlusions, difficulty flushing, or flow issues that could delay patient therapy. The product was distributed worldwide across all US states and multiple countries.

    Product
    BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2450-2021·2021-09-22

    Diagnostic reagent kits recalled for incorrect chemical composition

    Gibson Bioscience is recalling Potassium Hydroxide 10% diagnostic reagent kits (Lot 21137116, 11 units) manufactured with Hydrogen Peroxide 3% instead of the intended chemical. The wrong solution could cause inaccurate laboratory test results.

    Product
    Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is intended for use in the demonstration of yeast and fungal elements in wet clinical preparations. Potassium Hydroxide digests the proteinaceous material in the specimen, leaving the fungal c
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2443-2021·2021-09-22

    Hero Model 100 Smart Pill Dispenser Recalled for Software Dose-Prompting Error

    Hero Health is recalling the Model 100 smart pill dispenser due to a software defect causing the device to prompt users to take medication doses that have already been dispensed, creating overdose risk.

    Product
    The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2454-2021·2021-09-22

    Extension Set SMALLBORE Tubing with SmartSite Valves Recalled for Flushing Issues

    BD Extension Set SMALLBORE Tubing with SmartSite Valves (REF: 20019E) is being recalled due to flushing difficulties, flow issues, and occlusions that could delay therapy. Over 1.4 million units distributed worldwide are affected.

    Product
    BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2462-2021·2021-09-22

    BD Gravity Burette Set Needle-Free Connector Valves Recalled for Flow Issues

    CAREFUSION is recalling BD Gravity Burette Sets with needle-free connector valves that may develop flow restrictions and blockages, potentially delaying medication delivery. Approximately 29,130 units were distributed.

    Product
    BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2471-2021·2021-09-22

    Siemens ACUSON Juniper ultrasound system recalled for intermittent power supply failure

    Siemens Medical Solutions USA is recalling 15 ACUSON Juniper Diagnostic Ultrasound Systems worldwide due to intermittent power supply failures that render the devices inoperable. No injuries or illnesses have been reported.

    Product
    ACUSON Juniper Diagnostic Ultrasound System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2481-2021·2021-09-22

    Leica BOND Primary Antibody CDX2 Recalled for Performance Specification Issue

    Leica Microsystems recalls BOND Ready-To-Use Primary Antibody CDX2 (PA0375, Lot 69909) because the product may not perform as specified in its instructions for use. The recall affects 237 units distributed nationwide.

    Product
    BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2402-2021·2021-09-15

    Pipeline Flex Embolization Device Recalled for Potential Push Wire Fracture Risk

    Micro Therapeutics recalls Pipeline Flex Embolization Devices for potential push wire fractures in the delivery system during use. Device fractures in the Hypotube may result in malfunction during vascular procedures.

    Product
    Pipeline Flex Embolization Device
    Category
    Medical Device
    Distribution
    48 states
  • CriticalFDA (Devices)·Z-2392-2021·2021-09-15

    Eco-Med ultrasound gels and lotions recalled for bacterial contamination

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. are being recalled due to potential bacterial contamination. The FDA issued a Class I recall on August 18, 2021, advising health care providers to stop using all affected products.

    Product
    LiquaSonic Ultrasound Gel 5L, Model No. 001222
    Category
    Medical Device
    Distribution
    0 states