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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22401–22425 of 40339

  • ModerateFDA (Devices)·Z-3250-2018·2018-10-03

    Zimmer Biomet Recalls Vanguard 360 Knee Augments Due to Missing Bolt

    Zimmer Biomet is recalling 16 Vanguard 360 Revision Knee System tibial block augments because the sterile packages contained one bolt instead of the required two.

    Product
    Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number 185224 Intended for use in Total Knee Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3244-2018·2018-10-03

    Tosoh G8 Automated HPLC Analyzer Recalled for Missing 510(k) Software

    Tosoh Bioscience Inc is recalling eight G8 Automated HPLC Analyzers because they were distributed with software that lacks a 510(k).

    Product
    G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3249-2018·2018-10-03

    Zimmer Biomet Recalls Vanguard 360 Knee Augments Due to Missing Bolt

    Zimmer Biomet is recalling 16 Vanguard 360 Revision Knee System tibial block augments because the sterile packages contained only one bolt instead of the required two.

    Product
    Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3253-2018·2018-10-03

    Medtronic Diagnostic Catheter Recalled for Incorrect French Size Labeling

    Medtronic is recalling 250 units of DxTerity TRA 5F Diagnostic Catheters because the inner pouch may incorrectly display a 6 French size indicator instead of the correct 5 French size.

    Product
    Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-3252-2018·2018-10-03

    Biomet Sports Medicine Drill Bit Recalled for Incorrect Expiration Date Labeling

    Zimmer Biomet is recalling 217 units of Biomet Sports Medicine Juggerknot Long Flex Drill Bits because the expiration date is incorrectly listed on the label.

    Product
    Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Knee, Hand and Wrist and Hip repair.Stainless Steel, Sterile Item Number: 110016992
    Category
    Medical Device
    Distribution
    10 states
  • CriticalFDA (Devices)·Z-3012-2018·2018-09-26

    Ventana Recalls CINtec p16 Histology Reagent Due to Dispenser Defects

    Ventana Medical Systems is recalling 468 units of CINtec p16 Histology reagent because leaking dispensers may cause false negative test results.

    Product
    CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2972-2018·2018-09-26

    Pro-Med DORO LUCENT Transitional Member Recall for Potential Malfunction

    Pro-Med Instruments is recalling 31 DORO LUCENT Transitional Members because mixing design revisions may cause the headrest system to malfunction.

    Product
    DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-3003-2018·2018-09-26

    Ventana Anti-Pan Keratin Antibody Recalled for Leaking and Sticking Dispensers

    Ventana Medical Systems is recalling 354 units of Anti-Pan Keratin Primary Antibody due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2998-2018·2018-09-26

    Ventana iView DAB Detection Kit Recalled for Leaking and Sticking Dispensers

    Ventana Medical Systems is recalling iView DAB Detection Kits due to leaking and sticking reagent dispensers that may cause false negative immunohistochemistry results.

    Product
    iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3006-2018·2018-09-26

    Ventana CONFIRM anti-Progesterone Receptor Antibody Recalled for Dispenser Defects

    Ventana Medical Systems is recalling CONFIRM anti-Progesterone Receptor antibodies due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2970-2018·2018-09-26

    Pro-Med DORO LUCENT Headrest System Recalled for Malfunction Risk

    Pro-Med Instruments is recalling 30 DORO LUCENT Headrest Systems because mixing design revisions may cause malfunction during surgery.

    Product
    DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-3194-2018·2018-09-26

    Fresenius 2008T Hemodialysis Systems Recalled for Disinfectant Exposure Risk

    Fresenius Medical Care is recalling 80 hemodialysis systems because a power failure during cleaning may allow disinfectant to remain in the machine and be delivered to patients.

    Product
    2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2971-2018·2018-09-26

    Pro-Med Instruments Recalls DORO LUCENT Locking Transitional Member

    Pro-Med Instruments is recalling 31 DORO LUCENT Locking Transitional Members because mixing design revisions may cause the headrest system to malfunction.

    Product
    DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-3014-2018·2018-09-26

    Ventana Medical Systems Recalls Leaking HPV III Probe Dispensers

    Ventana Medical Systems is recalling 195 units of the INFORM HPV III Fam 16 Probe due to leaking and sticking dispensers that may cause false negative test results.

    Product
    INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3005-2018·2018-09-26

    Ventana ISH Protease 3 Reagent Recall for Leaking and Sticking Dispensers

    Ventana Medical Systems is recalling ISH Protease 3 reagents due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3008-2018·2018-09-26

    Ventana ISH iView Blue Detection Kit Recalled for Leaking Dispensers

    Ventana Medical Systems is recalling 559 units of the ISH iView Blue Detection Kit because the reagent dispensers may leak or stick.

    Product
    VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3011-2018·2018-09-26

    Ventana Recalls CINtec Histology Reagents Due to Dispenser Defects

    Ventana Medical Systems is recalling 120 units of CINtec Histology reagents worldwide because leaking dispensers may cause false negative test results.

    Product
    CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3015-2018·2018-09-26

    Ventana NEXES VEN IVIEW DAB Detection Kit Recall for Leaking Dispensers

    Ventana Medical Systems is recalling NEXES VEN IVIEW DAB Detection Kits due to leaking and sticking reagent dispensers that may cause false negative IHC results.

    Product
    NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3010-2018·2018-09-26

    Ventana anti-Helicobacter Pylori Reagent Recall Due to Dispenser Leaks

    Ventana Medical Systems is recalling anti-Helicobacter Pylori reagents because leaking dispensers may cause false negative test results.

    Product
    VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3000-2018·2018-09-26

    Ventana OptiView Amplification Kit Recalled for Leaking Dispensers

    Ventana Medical Systems is recalling OptiView Amplification Kits due to leaking dispensers that may cause false negative IHC results.

    Product
    OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2996-2018·2018-09-26

    Ventana OptiView DAB IHC Detection Kit Recalled for Leaking Dispensers

    Ventana Medical Systems is recalling OptiView DAB IHC Detection Kits because leaking dispensers may cause false negative test results.

    Product
    OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3004-2018·2018-09-26

    Ventana ultraView Universal Alkaline Phosphatase Red Detection Kit Recalled

    Ventana Medical Systems is recalling 8,211 units of the ultraView Universal Alkaline Phosphatase Red Detection Kit due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2999-2018·2018-09-26

    Ventana Medical Systems Recalls ultraView SISH DNP Detection Kit Due to Leaking

    Ventana Medical Systems is recalling 96 units of the ultraView SISH DNP Detection Kit because leaking and sticking dispensers may cause false negative IHC results.

    Product
    ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3007-2018·2018-09-26

    Ventana CONFIRM anti-Estrogen Receptor Antibody Recalled for Dispenser Defects

    Ventana Medical Systems is recalling CONFIRM anti-Estrogen Receptor antibodies due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3002-2018·2018-09-26

    Ventana iVIEW Blue Plus Detection Kit Recalled for Dispenser Leaks

    Ventana Medical Systems is recalling iVIEW Blue Plus Detection Kits because leaking dispensers may cause false negative IHC results.

    Product
    ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states