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.

Filters

Agency

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

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

26651–26675 of 27681

  • 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
  • HighFDA (Devices)·Z-0992-2013·2013-04-03

    Siemens Axiom Artis zeego Angiographic X-Ray System Recall

    Siemens is recalling 52 Axiom Artis zeego systems due to a potential risk to patients or operators during operation.

    Product
    Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0983-2013·2013-04-03

    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/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA70SSA) Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area; (Cat. No. 3FM70SSA)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0981-2013·2013-04-03

    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 covers units distributed in the US, Australia, Canada, and Japan.

    Product
    Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 3FS60SSA) Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips; (Cat. No. 3FS61SSA)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0979-2013·2013-04-03

    Cardinal Health Recalls Needle Counters Due to Packaging Defects

    Cardinal Health is recalling specific lots of sterile needle counters because small holes in the packaging may compromise sterility.

    Product
    Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA40SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0998-2013·2013-04-03

    Advanced Sterilization Products Recalls STERRAD 200 System Carriage Units

    Advanced Sterilization Products is recalling STERRAD 200 System Carriages because they may become dislodged under excessive load.

    Product
    STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0991-2013·2013-04-03

    Biomerieux VITEK 2 Compact Computer System Recall for Patient Data Error

    Biomerieux Inc. is recalling VITEK 2 Compact computer systems because a software issue could link test results to the wrong patient.

    Product
    VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models: (1) dc7100 8-port, Cat. #W0441; (2) dc7100 8-port (refurbished), Cat. #W0441R; (3) dc7700 8-port, Cat. #W0447; (4) dc7700 8-port (refurbished), Cat. #W0447R; (5) dc7800, Cat.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1017-2013·2013-04-03

    Medtronic Archer Super Stiff Guidewire Recalled for Coating Separation Risk

    Medtronic is recalling Archer Super Stiff Guidewires because the PTFE coating may separate from the wire during use.

    Product
    Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0990-2013·2013-04-03

    Biomerieux VITEK 2 XL Computer System Recalled for Patient Data Linking Errors

    Biomerieux Inc. is recalling VITEK 2 XL computer systems equipped with specific Hewlett-Packard PCs due to a potential risk of linking test results to the wrong patient.

    Product
    VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0996-2013·2013-04-03

    Smiths Medical Medfusion Syringe Pumps Recalled for Seal Migration Risk

    Smiths Medical is recalling six Medfusion Model 3500 syringe pumps in New Hampshire because a seal defect could cause the plunger rod seal to migrate during specific infusion conditions.

    Product
    Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1019-2013·2013-04-03

    Medtronic Archer Super Stiff Guidewires Recalled for Potential Kinking and Breaking

    Medtronic is recalling specific Archer Super Stiff Guidewires due to a manufacturing defect that may cause the device to kink or break during use.

    Product
    Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. Product Usage: The Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0995-2013·2013-04-03

    Kimberly-Clark Recalls KIMGUARD Container Filters Due to Sterility Concerns

    Kimberly-Clark is recalling KIMGUARD Container Filters because thin areas in some units may compromise the sterile barrier.

    Product
    KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-1015-2013·2013-04-03

    CareFusion Recalls Pyxis Anesthesia System Model 2000 Due to Drawer Inaccessibility

    CareFusion is recalling 2,637 Pyxis Anesthesia System Model 2000 units because system downtime or lock-ups can make medication drawers inaccessible.

    Product
    Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0989-2013·2013-04-03

    Biomerieux VITEK 2 60 Computer System Recalled for Data Linking Error

    Biomerieux Inc is recalling VITEK 2 60 computer systems due to a potential error that could link test results to the wrong patient.

    Product
    VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1002-2013·2013-04-03

    Vital Images Recalls Vitrea Software Due to Measurement Errors

    Vital Images is recalling Vitrea software versions prior to 6.3.3 due to a potential error in measurements generated when images are rotated during reconstruction.

    Product
    Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1021-2013·2013-04-03

    Microbiologics Recalls KWIK-QC Slides Due to Improper Fixation

    Microbiologics Inc is voluntarily recalling KWIK-QC Acid Fast and Mycobacterium slides because control organisms are not properly fixated, posing a contamination risk.

    Product
    Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides). Slide preparations serving as quality control challenges to demonstrate satisfactory performance of staining reagents.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0997-2013·2013-04-03

    Siemens Artis Angiographic X-Ray Systems Recalled for Image Registration Issues

    Siemens is recalling 81 Artis angiographic x-ray systems because a software issue may cause imprecise image registration during specific procedures.

    Product
    Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0977-2013·2013-04-03

    Mindray BS-200 Chemistry Analyzer Recalled for Inaccurate Clinical Results

    Mindray is recalling three BS-200 Chemistry Analyzers because clinical chemistry results may be inaccurate. The units were distributed in North Carolina and Texas.

    Product
    BS-200 Chemistry Analyzer Designed for clinical laboratory use.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0968-2013·2013-03-27

    Spacelabs Anesthesia Workstation Recall for Carbon Dioxide Defect

    Del Mar Reynolds Medical is recalling Spacelabs anesthesia workstations and service kits containing CAS I/II Absorbers due to a defect that may increase carbon dioxide levels in patient gas.

    Product
    Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. Anesthesia workstation for use in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0971-2013·2013-03-27

    DePuy Specialist 2 IM Rod Recalled for Potential Breakage Risk

    DePuy Orthopaedics is recalling Specialist 2 IM Rods and associated surgical techniques due to a potential risk of the rod breaking and leaving fragments in patients.

    Product
    Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510 PFC Sigma Knee…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0955-2013·2013-03-27

    Vascular Solutions Recalls Guardian II Hemostasis Valves Due to Air Embolism Risk

    Vascular Solutions, Inc. is recalling Guardian II and Guardian II NC Hemostasis Valves used in cardiopulmonary bypass because air may be introduced into the device, potentially leading to an air embolism.

    Product
    Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions…
    Category
    Medical Device
    Distribution
    43 states
  • SevereFDA (Devices)·Z-0953-2013·2013-03-27

    Exactech Recalls Knee Prosthesis Spacers Due to Dimensional Mismatch

    Exactech is recalling 123 Optetrak Logic knee prosthesis spacers and screws because a dimensional mismatch could allow interference between devices.

    Product
    Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0965-2013·2013-03-27

    Boston Scientific SQ-RX Subcutaneous Pulse Generators Recalled for Fuse Activation

    Boston Scientific is recalling SQ-RX Model 1010 subcutaneous pulse generators because an internal fuse may activate unintentionally, preventing the device from delivering therapy.

    Product
    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
    Category
    Medical Device
    Distribution
    17 states