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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5701–5725 of 13666

  • SevereFDA (Devices)·Z-2543-2024·2024-08-21

    RMU-2000 Automated Chest Compression Device Recalled Due to Motor Failure

    Defibtech is recalling the RMU-2000 Automated Chest Compression Device because a motor defect may cause the device to stop delivering compressions, potentially delaying critical therapy and resulting in patient injury or death.

    Product
    RMU-2000 Automated Chest Compression Device
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-2448-2024·2024-08-21

    Plum A+ and Plum A+3 Infusion Pump Batteries Recalled for Capacity Loss Defect

    ICU Medical is recalling Plum A+ and Plum A+3 infusion pump batteries due to a manufacturing defect that may cause premature capacity loss and reduced runtime. Approximately 14,744 units were distributed worldwide.

    Product
    Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS units marketed with the following descriptions: Plum A+ Mednet TM Firmware New 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2447-2024·2024-08-21

    Plum 360 Infusion Battery Recall Due to Manufacturing Defect

    ICU Medical is recalling Plum 360 Infusion System replacement batteries due to a manufacturing defect that may cause loss of capacity and decreased runtime earlier than expected. Approximately 11,961 units were distributed worldwide.

    Product
    Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following descriptions: Bomba de infusi¿n Plum 360 compatible con el software ICU Medical MedNet, Plum 360 Inf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2449-2024·2024-08-21

    Plum 360/A+ Spare Battery Defect Causes Accelerated Capacity Loss

    ICU Medical is recalling 130,826 units of Plum 360/A+ spare batteries due to a manufacturing defect that causes earlier-than-expected battery capacity loss and reduced runtime.

    Product
    Plum 360/A+ spare batteries. Item Number: SUB0000864.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2569-2024·2024-08-21

    Merit Medical pericardiocentesis kits recalled for syringe defects

    Merit Medical convenience kits containing plastic syringes have been recalled nationwide. The syringes have quality issues including leaks and breakage that may pose a risk to patient health.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentesis Tray - Fluid drainage tray), REF: PC101/B PC801 PC801/A PC802 PC802/A The Pericardiocentesis Kit is intended to withdraw fluid from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2559-2024·2024-08-21

    Merit Medical catheter extractor kits recalled for syringe quality defects

    Merit Medical is recalling 3,631 catheter extractor convenience kits due to defective syringes with leaks and breakage. The identified quality issues may compromise patient safety during catheter removal.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Outake, REF CET200 and CET300, The Catheter Extractor is a catheter accessory device intended for minimally invasive removal of tunneled long term catheters. T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2618-2024·2024-08-21

    Aurora 7 Surgical Light Heads Recalled for Cracked Weld Frames

    DKK Dai-Ichi Shomei is recalling 555 Aurora 7 surgical light heads because frame welds can crack, causing the frame to sag, the housing to crack, or the light head to detach.

    Product
    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2558-2024·2024-08-21

    Merit Medical Convenience Kits with Recalled Syringes Pose Quality Risks

    Merit Medical is recalling convenience kits containing syringes with quality defects including leaks and breakage that may pose patient safety risks in cardiac and vascular procedures.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/angioplasty kit), REF: K12T-10773 K12T-09284D K12T-10621 K12T-10800 K12T-12491 To support various vascular or cardiac dia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2544-2024·2024-08-21

    Beckman Coulter DxI 9000 Access analyzer software causes delayed test results

    Beckman Coulter has recalled 183 DxI 9000 Access analyzers due to a software issue that causes delays in test result reporting. When connected to a Laboratory Automation System, software versions 1.17 and below send out-of-sequence messages, potentially delaying patient treatment.

    Product
    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2561-2024·2024-08-21

    Merit Medical convenience kits recalled for syringe leaks and breakage

    Merit Medical is recalling 1,390 convenience kits containing plastic syringes with identified quality issues including leaks and breakage. The kits, distributed nationwide, may pose a risk to patient health.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF:K04-00791A An intravascular administration set is a device used to administer fluids from a container to a patient's vascular syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2579-2024·2024-08-21

    Merit Medical Convenience Kits Recalled for Syringe Leaks and Breakage

    Merit Medical is recalling medical convenience kits with defective syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health during procedures.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K05-02166B K05T-00380C K05T-01674B K05T-01863 K05T-01941C K05T-01955 K05T-02138 K05T-02159 K05T-02272G K05T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2577-2024·2024-08-21

    Merit Medical Catheter Kits Recalled for Syringe Leaks and Breakage Issues

    Merit Medical convenience kits containing defective plastic syringes are being recalled due to leaks, breakage, and quality issues that may harm patients. The recall affects approximately 4,027 kits distributed nationwide.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG/Worley advanced CSG (Introducer Catheter kit), REF: FCL-083-02/A WOR-CSG-B1-09/A WOR-CSG-B2-09/A WOR-CSG-BL1-09/A WOR-CSG-E-90/A For the int
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2567-2024·2024-08-21

    Convenience kits by Merit Medical recalled for syringe defects

    Merit Medical convenience kits containing defective syringes have been recalled nationwide. Identified quality issues including leaks and breakage may pose risks during cardiac and vascular procedures.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressure Monitoring Kit), REF: K12-03846 K12-04185A K12-03447 K12M-02489 K12-10056 K12-02489A K12-02097B K12-12335 K12-12192P K12-12079
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2570-2024·2024-08-21

    Merit Medical Convenience Kits Recalled for Defective Plastic Syringes

    Merit Medical is recalling 7,442 convenience kits containing defective syringes that may leak or break, posing a risk to patient health.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReSolve (Catheter and Tip Suction kit), REF: RTT14038MB/A The ReSolve Thoracostomy Tray is indicated for the percutaneous removal of air and fluid from the pleu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2557-2024·2024-08-21

    Merit Medical convenience kits recalled for syringe leaks and breakage

    Merit Medical convenience kits containing recalled syringes have quality issues including leaks and breakage that may pose a risk to patient health. The recall affects 2,388 kits distributed nationwide.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management System Kit, REF BRC-BAL-INT-SL/B An endoscope and accessories is a device used to provide access, illumination, and allow observ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2616-2024·2024-08-21

    BioButton Remote Monitoring Device Software Accuracy Issue

    A software anomaly causes the BioButton remote monitoring wearable device to report skin temperature readings slightly out of specification, affecting accurate health data collection in home and healthcare settings.

    Product
    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2563-2024·2024-08-21

    Merit Medical convenience kits with syringe quality issues recalled nationwide

    Merit Medical is recalling convenience kits containing syringes with quality issues including leaks and breakage that may pose a risk to patients receiving intravenous fluid administration.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2566-2024·2024-08-21

    Merit Medical Pressure Monitoring Kits with Defective Syringes Recalled

    Merit Medical is recalling 69 convenience kits containing defective syringes that may leak or break, potentially risking patient safety during medical procedures. The kits were distributed nationwide.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11 (Custom Pressure Monitoring Kit), REF: K11-00382C To support fluid administration into the body and physiological pressure monitoring. To support various v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2560-2024·2024-08-21

    Merit Medical Syringes in Convenience Kits Recalled for Leaks and Breakage

    Merit Medical convenience kits containing plastic syringes are recalled due to leaks, breakage, and quality defects that may pose a risk to patient health. Approximately 3,647 kits were distributed nationwide.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K02 (Custom Syringe Kit), REF: K02-00873A, Inject fluids into, or withdraw fluids from, the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2617-2024·2024-08-21

    Spinal Cord Stimulation Devices May Reset During Charging, Causing Transient Therapy Loss

    Boston Scientific spinal cord stimulation implants may reset during routine charging, causing brief loss of therapy. Patients may experience undesired sensations when stimulation restarts, potentially leading to surgical intervention requests.

    Product
    WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2562-2024·2024-08-21

    Merit Medical Convenience Kits with Defective Syringes Recalled

    Merit Medical convenience kits containing plastic syringes are recalled due to leaks, breakage, and quality issues that may pose risks to patients undergoing cardiac and vascular procedures.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF: K05-00203M K05-00511J K05-00547J K05-00612Q K05-00819A K05-01030H K05-01274D K05-01646 K05-01688A K05-01717B K05-01880K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2575-2024·2024-08-21

    Merit Medical Cardiac Catheter Kits Recalled for Syringe Leaks and Breakage

    Merit Medical's Prelude SNAP-H cardiac catheter kits are being recalled because their syringes may leak or break during use, potentially affecting cardiac procedures. No illnesses have been reported.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP-H (Introducer Catheter kit), REF: PLSH-1006/A PLSH-1007/A PLSH-1008/A PLSH-1009.5/A PLSH-2506/A PLSH-2507/A For the introduction of various t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2584-2024·2024-08-21

    Cepheid Sample Collection Device May Leak Causing Cross-Contamination Risk

    Cepheid specimen collection devices may leak after patient samples are inserted, creating risk of biohazard exposure and false positive test results. Affected devices are distributed in medical testing facilities worldwide.

    Product
    Cepheid, Sample Collection Device, Part: 900-0370
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2578-2024·2024-08-21

    Merit Medical convenience kits with recalled plastic syringes may leak or break

    Convenience kits from Merit Medical Systems containing recalled plastic syringes have identified quality issues including leaks and breakage that may pose a risk to patient health.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K09T-01138 K09T-04484A K09T-04757F K09T-04835H K09T-07256D K09T-07588B K09T-07611K K09T-07649K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2585-2024·2024-08-21

    Medical Device Recall: BD Kiestra Urine Culture Software May Cause Inaccurate Results

    Becton Dickinson & Co. is recalling the BD Kiestra Urine Culture Application due to a software issue that may cause inaccurate bacterial colony counts. This could impact patient diagnosis and treatment decisions.

    Product
    BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
    Category
    Medical Device
    Distribution
    17 states