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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13051–13075 of 13837

  • 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-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-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-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-2470-2021·2021-09-22

    Arjo Disposable Repositioning Sling Recalled for Trip Hazard Risk

    Getinge recalled 46,085 Arjo Disposable Repositioning Sling units because the sling loop straps pose a trip hazard. The affected devices were distributed nationwide to healthcare facilities.

    Product
    Arjo Disposable Repositioning Sling, Model AHD001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2446-2021·2021-09-22

    Siemens radiation therapy software may lose treatment structure data

    Siemens syngo.CT software used in radiation therapy systems may lose treatment structure data during edit and reopen operations, sending incomplete treatment information to planning systems.

    Product
    syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670
    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-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-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-2447-2021·2021-09-22

    MR MAGNETOM Imaging Systems Risk Data Loss in Treatment Planning

    Siemens MR MAGNETOM imaging systems may lose treatment planning data when editing structure sets after reopening a saved study, resulting in incomplete treatment plans being transmitted to planning systems.

    Product
    MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHETIC_CT Material Numbers: 11060815
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2482-2021·2021-09-22

    Braun ThermoScan PRO 6000 Ear Thermometer Recall: Burn Risk from Fluid Exposure

    Braun ThermoScan PRO 6000 ear thermometers may overheat if exposed to fluids and used before drying, risking burns to the user or patient. More than 1 million units are affected.

    Product
    Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adults in a professional use environment. Model: 6000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2449-2021·2021-09-22

    Pentax Upper GI Endoscopes and Colonoscopes: Updated Reprocessing Instructions

    Pentax Medical is updating reprocessing instructions for certain gastroscope and colonoscope models to ensure proper sterilization. Affected healthcare facilities should review and implement the updated instructions.

    Product
    Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Ins
    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-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-2448-2021·2021-09-22

    Pentax Medical Colonoscopes and Upper GI Scopes Updated Reprocessing Instructions

    Pentax is updating reprocessing instructions for over 28,000 colonoscopes and Upper GI scopes distributed nationwide between 2014 and 2021. Healthcare facilities should implement the updated procedures provided by the manufacturer.

    Product
    Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Tw
    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-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
  • HighFDA (Devices)·Z-2431-2021·2021-09-22

    Cordis Angiographic Catheter Recalled for Marker Band Dislodgement Risk

    Cordis is recalling angiographic catheters that may become entrapped between devices and vessel walls, risking marker band dislodgement during vascular procedures. Approximately 71,330 units were distributed worldwide.

    Product
    Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2445-2021·2021-09-22

    Radiation Therapy Software Risk: Data Loss in Treatment Planning

    Siemens radiation therapy planning software may lose data when editing treatment structures. Incomplete structure sets could be sent to the treatment planning system, affecting treatment plan accuracy.

    Product
    syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180
    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-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-2458-2021·2021-09-22

    BD needle-free connector valves may occlude or restrict fluid flow

    BD Burette Gravity Set needle-free connector valves may fail to flush or develop blockages, potentially delaying patient therapy. Lot 21015553 consists of approximately 630 units distributed worldwide.

    Product
    BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2456-2021·2021-09-22

    FDA recalls BD burette sets for connector valve occlusion and flow defects

    BD Gravity Burette Sets and Add-On Burette Sets are being recalled due to needle-free connector valve defects that may cause flushing difficulties, flow problems, or complete occlusions, potentially delaying therapy. The recall affects approximately 77,802 units distributed worldwide.

    Product
    BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031; BD Gravity Burette Set 20 DROP 1.2 Micron Filter 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV , REF: 10037032; BD GRAVITY BURETTE SET 60 DROP 2 Smartsite VALVES BALL DRIP CHAM
    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