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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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

26676–26700 of 27722

  • HighFDA (Devices)·Z-1077-2013·2013-04-17

    Siemens Medical Solutions Recalls Elekta MOSAIQ Software Due to Safety Risk

    Siemens Medical Solutions is recalling Elekta MOSAIQ Oncology Information System software versions below 2.41 due to a potential safety risk identified by the manufacturer.

    Product
    ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1061-2013·2013-04-17

    Stryker Recalls Baseplate Impactor Extractor Instruments Due to Handle Detachment

    Stryker Howmedica Osteonics is recalling 871 Baseplate Impactor Extractor instruments because the handle may detach from the cam during surgery.

    Product
    Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA A subsidiary of Stryker Corporation. Made in USA. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1096-2013·2013-04-17

    GE Healthcare Recalls LOGIQ Ultrasound Systems Due to Potential Skin Burn Risk

    GE Healthcare is recalling LOGIQ S8 and S7 ultrasound systems equipped with the S4-10-D probe due to a potential safety issue that may cause skin burns.

    Product
    GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The device is intended for use in ultrasound evaluation.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1100-2013·2013-04-17

    GE Healthcare Recalls Discovery MR750w Systems Due to Image Flip Defect

    GE Healthcare is recalling 46 Discovery MR750w 3.0T MRI systems worldwide due to a potential image flip issue that may result in incorrect anatomical localization.

    Product
    GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra,dynamic images of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1064-2013·2013-04-17

    Arrow International Recalls FiberOptix Intra-Aortic Balloon Catheter Kits

    Arrow International is recalling 188 units of FiberOptix Intra-Aortic Balloon Catheter Kits due to a potential internal leak at the fill port.

    Product
    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1072-2013·2013-04-17

    Elekta Precise Treatment Table Recalled for Column Rotation Defect

    Elekta, Inc. is recalling 443 Precise Treatment Tables because the column rotation can accidentally move from its locked position during radiation therapy.

    Product
    Precise Treatment Table. To be used as part of radiation therapy treatment process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1083-2013·2013-04-17

    GE Healthcare Recalls VMX Mobile X-ray Units Due to Arm Base Casting Issue

    GE Healthcare is recalling VMX and VMX Plus mobile X-ray units because a defect in the arm base casting may impact operator or patient safety.

    Product
    VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173. Product Usage: The VMX is a mobile radiography system incorporating stylish design for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1045-2013·2013-04-10

    Zimmer NexPosure Retractor Portals Recalled for Sterility Risk

    Zimmer, Inc. is recalling 58 NexPosure retractor portals due to a potential breach in the sterile inner pouch, which could lead to product contamination and patient infection.

    Product
    Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers: N1830R80-100, N1830R80-090¿, N1830R80-080¿, N1830R80-070¿, N1830R80-060, N1830R50-100, N1830R50-090, N1830R50-080, ¿ N1830R50-070, N1830R50-060, N1830L80-100, N1830L80-090…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0993-2013·2013-04-10

    Animas 2020 Insulin Pump Recall for False Alarm Component Issue

    Animas Corporation is recalling 7,157 Animas 2020 insulin pumps due to a component issue that may cause false alarms for loss of prime, occlusion, or no cartridge detected.

    Product
    Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1014-2013·2013-04-10

    Smiths Medical Recalls BCI Remote Alarm Cables for Capnograph Systems

    Smiths Medical is recalling 39 BCI Remote Alarm Cables because they may fail to transfer alarm signals to remote nurse alarm systems.

    Product
    Smiths Medical, BCI¿ Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiration carbon dioxide measurement equipment. Product Usage: The BCI¿ Remote Alarm Cable is designed for use with the 9004 Capnocheck¿…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1054-2013·2013-04-10

    LeMaitre Stent Guide Recalled Due to Compromised Sterility

    LeMaitre Vascular, Inc. is recalling LeMaitre Stent Guide strips because they were not sealed correctly during manufacturing, compromising their sterility.

    Product
    LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1050-2013·2013-04-10

    Horiba Medical Recalls ABX Micros IM2 Data Management System

    Horiba Medical is recalling 180 units of the ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.

    Product
    ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1036-2013·2013-04-10

    Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues

    Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions for Primus and Oncor linear accelerators to address performance defects and safety issues.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE AG TH, Part No. 5863506, Current R630; Product Usage: The intended use of…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1033-2013·2013-04-10

    Beckman Coulter Access 2 Immunoassay System Recall for Defective Pulley

    Beckman Coulter is recalling Access 2 Immunoassay Systems because a defective aluminum incubator belt pulley may create debris that falls into reaction vessels, risking erroneous test results.

    Product
    Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1029-2013·2013-04-10

    Philips Ingenuity TF PET/CT Software Update Addresses Potential Safety Risks

    Philips is updating software on one Ingenuity TF PET/CT system in Ohio to fix issues that could cause inaccurate readings or pose risks to patients and staff.

    Product
    Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1043-2013·2013-04-10

    Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues

    Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions for linear accelerators to address multiple performance defects and safety issues.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i 2.1, Part No. 8147675, Current R640; Product Usage: The intended…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1030-2013·2013-04-10

    Integra Ojemann Cortical Stimulator Recalled for Potential Electrical Injury Risk

    Integra Burlington MA, Inc. is recalling 371 Ojemann Cortical Stimulators because a non-intended voltage could be transmitted to patients during surgery.

    Product
    Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1055-2013·2013-04-10

    LeMaitre Vascular Recalls Glow 'N Tell Tape Due to Sterility Compromise

    LeMaitre Vascular is recalling Glow 'N Tell 20 cm Tape because manufacturing defects compromised the sterility of the devices.

    Product
    Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1060-2013·2013-04-10

    Polymedco Recalls OC-Light iFOBT Test Strips Due to Stability Issues

    Polymedco is recalling OC-Light iFOBT test strips because they may not be stable through their labeled shelf-life, potentially causing false negative results.

    Product
    Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1059-2013·2013-04-10

    Polymedco OC-Light iFOBT Test Strips Recalled for Potential False Negatives

    Polymedco is recalling OC-Light iFOBT test strips because they may not be stable through their labeled shelf-life, potentially causing false negative results.

    Product
    Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1031-2013·2013-04-10

    Medtronic Recalls Prostiva RF Therapy Generators Due to Static Electricity Risk

    Medtronic is recalling 848 Prostiva RF Therapy Generators because static electricity may unintentionally start or stop the treatment process if the footswitch is not connected.

    Product
    Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1035-2013·2013-04-10

    Beckman Coulter Recalls UniCel DxC 600i Synchron Access Clinical Systems

    Beckman Coulter is recalling 956 UniCel DxC 600i Synchron Access Clinical Systems because a defective incubator belt pulley may create debris that falls into reaction vessels, potentially causing erroneous test results.

    Product
    UniCel DxC 600i Synchron Access Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1034-2013·2013-04-10

    Beckman Coulter Synchron LXi 725 Clinical System Recalled for Defective Pulley

    Beckman Coulter is recalling 83 Synchron LXi 725 Clinical Systems because a defective incubator belt pulley may create debris that falls into reaction vessels, potentially causing erroneous test results.

    Product
    Synchron LXi 725 Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0984-2013·2013-04-03

    Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects

    Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall affects units distributed in the US, Australia, Canada, and Japan.

    Product
    Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double Removable Numbered Foam Blocks (Cat. No. 3FF80SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2013·2013-04-03

    Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects

    Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall affects units distributed in the US, Australia, Canada, and Japan.

    Product
    Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 3FM40SSA)…
    Category
    Medical Device
    Distribution
    Distributed nationwide