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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

8276–8300 of 27393

  • HighFDA (Devices)·Z-1280-2023·2023-03-29

    Wearable ECG smartwatch software bug eliminates physician review

    Withings Scan Monitor/ScanWatch (model hwa09) has a software defect preventing physicians from reviewing ECG recordings, which is critical to the device's FDA clearance requirement for physician-supervised use. Users should discontinue use until the defect is corrected.

    Product
    Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1267-2023·2023-03-29

    DePuy Attune Tibial Insert Recalled for Excessive Radiation Exposure

    DePuy Orthopaedics is recalling Attune Posterior tibial insert implants that received excessive gamma radiation during manufacturing, which may degrade the material properties of the knee replacement component.

    Product
    Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1277-2023·2023-03-29

    Cardiosave Hybrid Intra-Aortic Balloon Pump Performance Issue Recall

    Datascope Corp. is recalling specific Cardiosave Hybrid intra-aortic balloon pumps due to a Safety Disk performance issue that may reduce balloon inflation and therapeutic benefit.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1278-2023·2023-03-29

    Cardiosave IABP Safety Disk Model 0202-00-0140 Recalled for Performance Defect

    Datascope Corp. is recalling 669 Cardiosave IABP Safety Disks due to a performance defect that may reduce balloon inflation during cardiac support therapy. The affected devices may not provide adequate augmentation to patients requiring mechanical circulatory support.

    Product
    Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1266-2023·2023-03-29

    Attune Revision Tibial Insert Recalled for Excessive Gamma Radiation Exposure

    DePuy Orthopaedics is recalling 7 units of the Attune Revision Tibial Insert that received excess gamma radiation during manufacturing, which may degrade implant material properties.

    Product
    Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1264-2023·2023-03-29

    Orthopedic Tibial Insert Recalled Due to Excessive Radiation Exposure

    DePuy Orthopaedics is recalling Attune Revision LPS Tibial Insert devices (Lot JP9016) because they received excessive gamma radiation during manufacturing, which may compromise material properties.

    Product
    Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1279-2023·2023-03-29

    Cardiosave IABP Pneumatic Interface Module Recalled for Performance Issue

    Datascope Corp. recalls the Cardiosave IABP Pneumatic Interface Module due to a Safety Disk performance issue that may reduce balloon inflation. Ten specific units with identified serial numbers are affected.

    Product
    Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1276-2023·2023-03-29

    Cardiosave Hybrid intra-aortic balloon pump safety disk defect may reduce therapy efficacy

    Datascope's Cardiosave Hybrid intra-aortic balloon pump may have a faulty Safety Disk that reduces balloon inflation and cardiac augmentation. No injuries reported.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, and 0998-00-0800-65
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1263-2023·2023-03-29

    Orthopedic Implant Recall: Excessive Radiation Exposure in Revision Tibial Insert

    DePuy Orthopaedics recalls 7 units of Attune Revision LPS Tibial Inserts (Part 151760118, Lot JP6452) distributed worldwide due to excessive gamma radiation during manufacturing. This overage may result in material property changes.

    Product
    Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1190-2023·2023-03-22

    Closed Suction System Manifold Cracking Poses Respiratory Circuit Leak Risk

    Avanos Medical recalls BALLARD ACCESS Closed Suction System units due to manifold cracking, which can cause respiratory circuit leaks and inadequate ventilation in neonatal and pediatric patients.

    Product
    BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1189-2023·2023-03-22

    BALLARD ACCESS Closed Suction System Manifold May Crack and Leak

    Avanos Medical is recalling 780 units of the BALLARD ACCESS Closed Suction System due to manifold cracking that can leak the respiratory circuit, potentially causing inadequate ventilation in neonatal and pediatric patients.

    Product
    BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1257-2023·2023-03-22

    Beckman Coulter Access Immunoassay Analyzers Recalled for Defective Nut Bands

    Beckman Coulter is recalling approximately 4,100 laboratory immunoassay analyzers due to defective nut bands that may cause operational failures and erroneous patient test results.

    Product
    Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1248-2023·2023-03-22

    TFN Femoral Nails dimensions mislabeled, may measure 170mm or 200mm

    Synthes recalled TFN-Advanced Femoral Nails because some units have incorrect dimensions: nails labeled 200mm may measure 170mm, while those labeled 170mm may measure 200mm. This dimensional mismatch could compromise surgical fixation.

    Product
    TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1238-2023·2023-03-22

    BD Insulin Syringes Recalled Due to Nonsterile Condition

    BD Insulin Syringes (Catalog 329420) are being recalled due to nonsterile conditions that could expose patients to pathogenic microorganisms and increase infection risk. The recall affects 961,000 units distributed worldwide.

    Product
    BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Single Unit Scale. Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329420
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1247-2023·2023-03-22

    TFN-Advanced Femoral Nails May Have Incorrect Length Markings

    Synthes TFN-Advanced Femoral Nails labeled as 200mm may measure 170mm, and vice versa. Healthcare providers should verify actual dimensions before surgical use.

    Product
    TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1254-2023·2023-03-22

    Amicus MNC Apheresis Kit at Risk of Stress Leak in Centrifuge Packs

    Fenwal Inc is recalling certain batches of the Amicus MNC Apheresis Kit due to a potential for centrifuge packs to develop stress leaks. Affected units were distributed nationwide and internationally.

    Product
    Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1245-2023·2023-03-22

    Fusion Bioline Vascular Graft recalled due to manufacturing straightness defect

    Maquet Cardiovascular is recalling one Fusion Bioline Vascular Graft from lot 25162546 that failed straightness testing. The graft could reduce blood flow or cause tension, potentially leading to bleeding and pseudo-aneurysm.

    Product
    Fusion Bioline Vascular Graft, Part number M00201503046B0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1259-2023·2023-03-22

    Radiation Therapy Software May Not Properly Execute Heart-Protection Breath Hold

    Brainlab ExacTrac Dynamic software used in charged-particle radiation therapy systems may not properly execute Deep Inspiration Breath Hold (DIBH) functionality, a heart-protection technique. The issue affects 56 systems across the United States.

    Product
    Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1243-2023·2023-03-22

    BD Ultra-Fine Insulin Syringes Recalled Due to Nonsterile Condition

    Becton Dickinson is recalling BD Ultra-Fine Insulin Syringes (Catalog Number 326719) due to a nonsterile condition that could expose patients to pathogenic microorganisms and local infection. Approximately 80,500 units distributed worldwide are affected.

    Product
    BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326719
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1256-2023·2023-03-22

    Ambulance cot may separate due to insufficient epoxy in assemblies

    Stryker's Power-PRO 2 ambulance cots may separate at head or foot due to insufficient epoxy. Four affected units in NY and VA should be removed from service immediately.

    Product
    Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1241-2023·2023-03-22

    BD Insulin Syringes Recalled for Potential Nonsterile Condition

    Becton Dickinson & Company is recalling 1.17 million BD Ultra-Fine Insulin Syringes due to a nonsterile manufacturing defect that could expose patients to pathogenic microorganisms and increase infection risk.

    Product
    BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326678
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1249-2023·2023-03-22

    Plato 17 Microcatheter Recalled Due to Loose Particle Risk

    Scientia Vascular is recalling Plato 17 Microcatheters due to manufacturing defects that may introduce loose particles into the catheter lumen, potentially causing blood vessel blockage or inflammatory reactions.

    Product
    Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1255-2023·2023-03-22

    Medical Device Apheresis Kit Recalled Due to Stress Leak Risk

    Fenwal Inc is recalling 6,564 units in certain lots of Amicus apheresis kits because centrifuge packs may develop a stress leak. No illnesses or injuries have been reported.

    Product
    Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1258-2023·2023-03-22

    Dimension Tacrolimus Diagnostic Cartridge Recalled for Measurement Imprecision

    Siemens is recalling Dimension Tacrolimus diagnostic test cartridges (lots GA2286, GA3047, GA3171) due to confirmed measurement imprecision that could lead to incorrect drug dosing and potential organ failure or toxicity.

    Product
    Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension¿ clinical chemistry system SMN: 10700795 (DF207)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1240-2023·2023-03-22

    BD Ultra-Fine Insulin Syringe 0.5mL Recalled for Nonsterility Risk

    Becton Dickinson is recalling approximately 1.1 million BD Ultra-Fine Insulin Syringes due to nonsterility concerns. The affected syringes may expose patients to pathogenic microorganisms and risk of local infection.

    Product
    BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326713
    Category
    Medical Device
    Distribution
    Distributed nationwide