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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39626–39650 of 40356

  • HighFDA (Devices)·Z-0032-2013·2012-10-17

    Winco Recalls Caremor Cliner Patient Recliners Due to Frame Defect

    Winco Mfg. is recalling Caremor Cliner patient recliners because a back frame may not snap properly onto the chair frame.

    Product
    Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 535 Serial No. 535A-104522***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0046-2013·2012-10-17

    Beckman Coulter Recalls Access Folate Calibrators Due to Falsely Elevated Results

    Beckman Coulter is recalling Access Folate Calibrators because they may produce falsely elevated results that could mask a folate deficiency.

    Product
    Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0025-2013·2012-10-17

    Advanced Neuromodulation Systems Recalls Eon Mini Implantable Pulse Generators

    Advanced Neuromodulation Systems is recalling 56 Eon Mini Implantable Pulse Generators manufactured in April 2012 due to a potential internal battery contact issue that could cause painful stimulation surges.

    Product
    The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0038-2013·2012-10-17

    Medtronic Premier Anterior Cervical Plate Screw Block Recall

    Medtronic is recalling 247 units of the Premier Anterior Cervical Plate System Screw Block because gauge lines may be misaligned, potentially causing screws to be measured as 1 mm shorter than their actual length.

    Product
    PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0021-2013·2012-10-17

    Beckman Coulter Recalls UniCel DxH 800 Hematology Analyzers

    Beckman Coulter is recalling UniCel DxH 800 hematology analyzers because drain ports may plug, causing biohazard exposure or incorrect test results.

    Product
    Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0047-2013·2012-10-17

    Beckman Coulter Recalls Access Folate Calibrators Due to Falsely Elevated Results

    Beckman Coulter is recalling Access Folate Calibrators because they may produce falsely elevated results that could mask a folate deficiency.

    Product
    Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0037-2013·2012-10-17

    Medtronic Atlantis Anterior Cervical Plate Screw Module Recall

    Medtronic is recalling Atlantis Anterior Cervical Plate System screw modules because gauge lines may be misplaced, leading to inaccurate screw length measurements.

    Product
    ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0031-2013·2012-10-17

    Winco Recalls Caremor Cliner Patient Recliner Chairs Due to Frame Defect

    Winco Mfg. is recalling Caremor Cliner recliner chairs because a back frame failed to snap properly onto the chair frame.

    Product
    Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No. 536A-101475***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0052-2013·2012-10-17

    Terumo Sarns Centrifugal System Control Module Recalled for Power Loss

    Terumo CVS is recalling Sarns Centrifugal System Control modules due to a report of power loss during cardiopulmonary bypass.

    Product
    Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0036-2013·2012-10-17

    Medtronic Atlantis Anterior Cervical Plate Screw Module Recalled for Measurement Error

    Medtronic is recalling the Atlantis Anterior Cervical Plate System Variable Angle Screw Module because gauge lines may be misaligned, leading to inaccurate screw length measurements.

    Product
    ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0016-2013·2012-10-17

    Beckman Coulter Recalls Active Renin IRMA Kit Due to Stability Issues

    Beckman Coulter is recalling the Active Renin IRMA Kit because decreased stability in coated tubes may cause falsely elevated test results.

    Product
    Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0035-2013·2012-10-17

    Beckman Coulter Recalls TetraCXP Software for Labeling Updates

    Beckman Coulter is recalling TetraCXP software and CYTO-STAT reagents to update specimen stability claims in the product labeling.

    Product
    TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0041-2013·2012-10-17

    IDS-iSYS Ostase BAP Control Set Recalled for Incorrect Labeling

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS Ostase BAP Control Sets because they are labeled as IVDs but are not registered for that use in the US.

    Product
    IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0039-2013·2012-10-17

    IDS Urine BETA CrossLaps ELISA Recalled for Incorrect IVD Labeling

    Immunodiagnostics Systems Ltd is recalling IDS Urine BETA CrossLaps ELISA kits because they were labeled for in vitro diagnostic use despite not being registered for that purpose in the US.

    Product
    IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps¿ ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0034-2013·2012-10-17

    Beckman Coulter Recalls CYTO-STAT Reagents Due to Labeling Stability Claims

    Beckman Coulter is recalling CYTO-STAT tetraCHROME reagents because stability claims in the product labeling need to be updated to align with current standards.

    Product
    CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0048-2013·2012-10-17

    Siemens syngo.plaza Radiological Image Processing System Recall

    Siemens is recalling 11 syngo.plaza systems due to a software defect where archived studies may be missing from the database.

    Product
    Siemens syngo.plaza radiological image processing system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0045-2013·2012-10-17

    IDS-iSYS Intact PINP Control Set Recalled for Incorrect IVD Labeling

    Immunodiagnostics Systems Ltd is recalling 29 units of IDS-iSYS Intact PINP Control Set because they were labeled as In Vitro Diagnostics (IVD) despite not being registered for that use in the US.

    Product
    IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP Assay on the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0043-2013·2012-10-17

    IDS-iSYS N-Mid Osteocalcin Control Set Recalled for Labeling Errors

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS N-Mid Osteocalcin Control Sets because they were labeled as IVDs instead of Research Use Only.

    Product
    IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid¿ Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0030-2013·2012-10-17

    Siemens Healthcare Recalls Phenobarbital Assay Kits Due to Imprecision

    Siemens Healthcare Diagnostics is recalling specific lots of Emit 2000 and Syva Emit Phenobarbital Assays because they may show higher imprecision when used on Beckman Coulter AU Systems.

    Product
    Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0029-2013·2012-10-17

    Alere Recalls Triage TOX Drug Screen Kits Due to Mislabeled Boxes

    Alere San Diego, Inc. is recalling Triage TOX Drug Screen kits because the boxes containing the test devices were mislabeled.

    Product
    Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0040-2013·2012-10-17

    Immunodiagnostics Systems Recalls IDS-iSYS Ostase BAP Assay Due to Labeling Error

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS Ostase BAP assays because they were labeled for in vitro diagnostic use despite not being registered for that purpose in the US.

    Product
    IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0044-2013·2012-10-17

    IDS-iSYS Intact PINP Assay Recalled for Incorrect IVD Labeling

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS Intact PINP assays because they were labeled for In Vitro Diagnostic use but are not registered for that purpose in the US.

    Product
    IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0055-2013·2012-10-17

    ICU Medical Recalls 3 Port Off Manifold Due to Component Commingling

    ICU Medical is recalling 60 units of a 3 Port Off Manifold waste system because a 60 drop micro drip chamber may have been included on a 20 drop macro drip set.

    Product
    3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0033-2013·2012-10-17

    Beckman Coulter Recalls CYTO-STAT Reagents Due to Labeling Updates

    Beckman Coulter is recalling CYTO-STAT tetraCHROME reagents because stability claims in the product labeling need to be updated to align with current standards.

    Product
    CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0042-2013·2012-10-17

    IDS-iSYS Osteocalcin Assay Recalled for Incorrect IVD Labeling

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS N-Mid Osteocalcin assays because they were labeled as In Vitro Diagnostics (IVD) despite not being registered for that use in the US.

    Product
    IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Assay is intended for the quantitative determination of Osteocalcin in human serum or plasma on the IDS-iSYS Multi-Discipline Automated…
    Category
    Medical Device
    Distribution
    Distributed nationwide