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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38726–38750 of 40449

  • LowFDA (Devices)·Z-1047-2013·2013-04-10

    Siemens Dimension EXL LM STM Recalled for System Check Failures

    Siemens is recalling 2,207 Dimension EXL LM STM analyzers worldwide due to System Check failures that cause inconvenience but do not affect test results.

    Product
    Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). Intended to measure a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    0 states
  • 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
  • ModerateFDA (Devices)·Z-1013-2013·2013-04-03

    bioMerieux VITEK 2 Streptococcus Card Recalled for Incorrect Package Insert

    Biomerieux Inc is recalling VITEK 2 AST-ST01 Streptococcus Susceptibility Cards because the package insert did not list the correct limitations of use and performance requirements.

    Product
    bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0980-2013·2013-04-03

    Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects

    Cardinal Health is recalling sterile needle counters with blade disarmers because small holes in the packaging may compromise sterility.

    Product
    Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FS30SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1016-2013·2013-04-03

    Synthes Dens Instrument Set Recalled Due to Lack of Indicated Screws

    Synthes USA HQ, Inc. is recalling 148 Dens Instrument Sets because there are no screws specifically indicated for the procedure.

    Product
    Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Dens instrument Set has been designed to facilitate internal fixation of the odontoid process for the reduction of Type II and shallow Type III…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0976-2013·2013-04-03

    Becton Dickinson Recalls BD MAX PCR Cartridges Due to Sealing Defects

    Becton Dickinson & Co. is recalling BD MAX PCR Cartridges because they may not seal properly, potentially causing false or invalid test results.

    Product
    BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for…
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0994-2013·2013-04-03

    Toshiba Infinix-i X-Ray System Recalled for Software Image Error

    Toshiba is recalling 95 Infinix-i X-Ray systems because a software error may display incorrect images or cause image loss during fluoroscopy.

    Product
    Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide