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 the agency’s own highest classification or reported deaths or serious injuries, 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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14601–14625 of 27500

  • CriticalFDA (Devices)·Z-0588-2020·2019-12-18

    Cook CrossCath Support Catheter Recalled for Manufacturing Error

    Cook Inc. is recalling six CrossCath Support Catheters due to a manufacturing error that may cause radiopaque marker bands to be too loose or too tight.

    Product
    CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Devices)·Z-0587-2020·2019-12-18

    Cook CrossCath Support Catheter Recall Due to Manufacturing Error

    Cook Inc. is recalling 20 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.

    Product
    CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Devices)·Z-0675-2020·2019-12-18

    Cognision Subject Kit Recalled for Potential B. cepacia Contamination

    Neuronetrix Solutions is recalling 3,108 units of the Cognision Subject Kit (Clinical Grade) due to potential contamination with Burkholderia cepacia.

    Product
    Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrodes. Order No. D5000, Part No. PN-1720 - Product Usage: An electroconductive cream for use with external electrodes to reduce the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0611-2020·2019-12-18

    Encore Medical Recalls EMPOWR Locking Femoral Impactor Due to Tip Breakage

    Encore Medical is recalling 410 EMPOWR Locking Femoral Impactors because the tips may break off during surgery. This defect can cause off-axis loading, device failure, and potential long-term complications.

    Product
    EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0610-2020·2019-12-18

    Smiths Medical Medfusion 4000 Syringe Pump Firmware Recall

    Smiths Medical is recalling 626 Medfusion 4000 Syringe Pumps due to a firmware anomaly that may disable battery alarms and interrupt therapy.

    Product
    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0662-2020·2019-12-18

    Paragon 28 Recalls Mislabelled Titan 3-D Wedge Implants

    Paragon 28, Inc. is recalling 64 Titan 3-D Wedge implant kits because they are permanently mislabeled with the wrong size, which could cause surgical delays.

    Product
    P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-0623-2020·2019-12-18

    Integra LifeSciences Recalls CUSA Clarity Ultrasonic Tissue Ablation Systems

    Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required drying time criteria.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-0668-2020·2019-12-18

    Boston Scientific Recalls Habib EUS RFA Electrode Tips Due to Thermal Injury Risk

    Boston Scientific is recalling 179 Habib EUS RFA electrode tips because capacitive coupling may cause unintended thermal injury to tissue outside the treatment area.

    Product
    Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0589-2020·2019-12-18

    Cook Inc. Recalls CrossCath Support Catheters Due to Manufacturing Error

    Cook Inc. is recalling 43 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.

    Product
    CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-0664-2020·2019-12-18

    Abbott Medical Recalls Radiofrequency Grounding Pads Due to Liner Orientation Error

    Abbott Medical is recalling 8,940 radiofrequency grounding pads nationwide because an incorrectly oriented release liner may leave film on the pad, interfering with skin contact and causing uneven heating.

    Product
    Radiofrequency Grounding Pad, REF RF-DGP-L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0670-2020·2019-12-18

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta Inc is recalling Monaco Radiation Treatment Planning System software due to incorrect energy usage during dose calculation.

    Product
    Monaco Radiation Treatment Planning System (RTP) System
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0655-2020·2019-12-18

    CP Medical Recalls Coated PGA Sutures for Tensile Strength Failure

    CP Medical Inc is recalling 2,124 coated PGA sutures because they failed to meet USP minimum average value for knot pull strength.

    Product
    Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0678-2020·2019-12-18

    Maquet ROTAFLOW Drive Recalled for Loose Cable Connection

    Maquet is recalling 11 ROTAFLOW Drive units because a loose cable connection may cause fluctuating flow values on the console.

    Product
    Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0656-2020·2019-12-18

    Ligamax 5 mm Endoscopic Clip Applier Recalled for Sterility Breach Risk

    Ethicon Endo-Surgery Inc is recalling Ligamax 5 mm Endoscopic Multiple Clip Appliers due to potential holes in the Tyvek lidding that could breach sterility.

    Product
    Ligamax 5 mm Endoscopic Multiple Clip Applier
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0677-2020·2019-12-18

    Getinge Pediatric Diffusion Membrane Oxygenator Recalled for Sterility Concerns

    Getinge is recalling 3,633 units of Quadrox-iD Pediatric Diffusion Membrane Oxygenators because the sterile barrier system may be compromised.

    Product
    Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0672-2020·2019-12-18

    Conformis Recalls iTotal CR Knee Replacement System Due to Fit Issues

    Conformis, Inc. is recalling the iTotal CR Knee Replacement System because the polyethylene inserts did not securely fit into the cobalt chrome tray implant.

    Product
    iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0667-2020·2019-12-18

    Boston Scientific Recalls Habib EUS RFA Electrode Tips Due to Thermal Injury Risk

    Boston Scientific is recalling 139 Habib EUS RFA electrode tips because capacitive coupling may cause thermal injury to tissue outside the target area.

    Product
    Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0541-2020·2019-12-11

    GE Healthcare Recalls Giraffe Infant Warmers Due to Latching Defect

    GE Healthcare is recalling Giraffe infant warmers because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.

    Product
    Giraffe Incubator infant warmer
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0609-2020·2019-12-11

    Lens.com Recalls Alcon Air Optix Night & Day Aqua Contact Lenses

    Lens.com is recalling specific lots of Alcon Air Optix Night & Day Aqua contact lenses because they may be counterfeit and have microbial issues.

    Product
    Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0538-2020·2019-12-11

    GE Healthcare Recalls Giraffe OmniBed Infant Warmers Due to Latch Defect

    GE Healthcare is recalling Giraffe OmniBed infant warmers because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.

    Product
    Giraffe OmniBed infant warmer
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0593-2020·2019-12-11

    Stryker Recalls Disposable Tourniquet Cuffs Due to Air Leak Risk

    Stryker is recalling 16,380 disposable tourniquet cuffs because they may leak air, causing a loss of vascular occlusion during surgery.

    Product
    Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 5921-018-235 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0539-2020·2019-12-11

    GE Healthcare Recalls Giraffe OmniBed Carestations Due to Latching Defect

    GE Healthcare is recalling Giraffe OmniBed Carestations because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.

    Product
    Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX. infant warmer
    Category
    Medical Device
    Distribution
    0 states