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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38701–38725 of 40449

  • 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
  • ModerateFDA (Devices)·Z-1044-2013·2013-04-10

    Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Performance Defects

    Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and safety issues that were not considered critical for immediate correction.

    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 2.0, Part No. 8139847, Current R630; Product Usage: The intended…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1038-2013·2013-04-10

    Siemens COHERENCE RT Therapist Software Recall for Performance Defects

    Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions to address performance defects and non-critical safety issues identified during final system testing.

    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 Impression TH, Part No. 7341410, Current R630; Product Usage: The…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1027-2013·2013-04-10

    Advanced Sterilization Products Recalls STERRAD 200 Sterilization Systems

    Advanced Sterilization Products is recalling STERRAD 200 Sterilization Systems because they may emit unusual odors into the surrounding environment.

    Product
    STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1042-2013·2013-04-10

    Siemens COHERENCE RT Therapist Software Recall for Performance Defects

    Siemens is recalling COHERENCE RT Therapist software versions due to performance defects and non-critical safety issues identified during final system testing.

    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, Part No. 7341428, Current R610/R630; Product Usage: The intended…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1037-2013·2013-04-10

    Siemens COHERENCE RT Therapist Software Recall for Safety Defects

    Siemens 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 TH, Part No. 7339125, - Current R630; Product Usage: The intended use of…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1053-2013·2013-04-10

    Cooper Surgical Recalls LEEP RediKit Due to Incorrect Anesthetic Labeling

    Cooper Surgical is recalling LEEP RediKit products because the tray lid label incorrectly lists Xylocaine, while the kit actually contains Polocaine.

    Product
    LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1026-2013·2013-04-10

    Advanced Sterilization Products Recalls STERRAD 100NX Sterilization Systems

    Advanced Sterilization Products is recalling STERRAD 100NX Sterilization Systems because they may emit unusual odors into the surrounding environment.

    Product
    STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1057-2013·2013-04-10

    Arrow Berman Angiographic Catheter Recall Due to Outdated Contrast Medium Labeling

    Arrow International is recalling Berman Angiographic Catheters because the instructions reference a discontinued contrast medium. The firm is updating the labeling.

    Product
    Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Angiographic Catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and…
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-1049-2013·2013-04-10

    Siemens Dimension Phosphorus Reagent Cartridge Recalled for Result Interference

    Siemens is recalling Dimension Phosphorus reagent cartridges because they can cause falsely low creatinine results when processed near open wells.

    Product
    Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) method used on the Dimension(R) clinical chemistry system is an in vitro diagnostic test intended for the quantitative measurement of phosphorus in human serum, plasma, and urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1056-2013·2013-04-10

    BD Vacutainer Urinalysis Transfer Straw Kit Recalled for Mislabeling

    Becton Dickinson is recalling BD Vacutainer Urinalysis Transfer Straw Kits due to incorrect polybag labeling that may cause users to mistake the tube for a culture and sensitivity tube.

    Product
    BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Company, Franklin Lakes, NJ USA, The kit consists of a transfer straw and urinalysis tube intended for UA chemistry urine testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1039-2013·2013-04-10

    Siemens COHERENCE RT Therapist Software Recalled for Performance Defects

    Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and non-critical 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 TH 2.0, Part No. 8139839, Current R630; Product Usage: The intended…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1024-2013·2013-04-10

    Zyno Medical Recalls Z-800 Volumetric Infusion Systems for Software Update

    Zyno Medical LLC is recalling 2,589 Z-800 Volumetric Infusion Systems to update the Preventative Maintenance schedule and add software to monitor fluid volume.

    Product
    Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1041-2013·2013-04-10

    Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues

    Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and non-critical safety issues identified during final system testing.

    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 TH 2.2, Part No. 10568431, Current R640; Product Usage: The intended use…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1028-2013·2013-04-10

    Roche cobas x 480 Reagent Reservoirs Recalled for Pipetting Errors

    Roche Diagnostics is recalling certain lots of cobas x 480 reagent reservoirs because a missing separation may cause pipetting errors, leading to delayed results and wasted reagent.

    Product
    Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas¿ CT/NG 4800 System, for in vitro diagnostics.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1032-2013·2013-04-10

    Beckman Coulter Access Immunoassay System Recalled for Defective Belt Pulley

    Beckman Coulter is recalling Access Immunoassay Systems because a defective belt pulley creates debris that may cause erroneous test results.

    Product
    Access Immunoassay 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
  • ModerateFDA (Devices)·Z-1040-2013·2013-04-10

    Siemens COHERENCE RT Therapist Software Recall for Performance Defects

    Siemens is recalling COHERENCE RT Therapist software versions to address performance defects and safety issues identified during final system testing.

    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 TH 2.1, Part No. 8147667, Current R640; Product Usage: The intended use…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1046-2013·2013-04-10

    Siemens Dimension EXL LM Analyzer Recalled for System Check Failures

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

    Product
    Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1048-2013·2013-04-10

    Siemens Dimension EXL 200 Recalled for System Check Failures

    Siemens Healthcare Diagnostics is recalling 2,207 Dimension EXL 200 analyzers worldwide due to increased System Check failures that cause inconvenience but do not impact test results.

    Product
    Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1025-2013·2013-04-10

    Viscot Medical Recalls Dual Tip Markers Due to Inconsistent Ink Flow

    Viscot Medical LLC is recalling 458,589 sterile dual tip markers because the black permanent ink side has inconsistent ink flow.

    Product
    Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.
    Category
    Medical Device
    Distribution
    Distributed nationwide