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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20226–20250 of 27647

  • HighFDA (Devices)·Z-1110-2017·2017-02-08

    Biom'up Recalls Renovix Collagen Membranes Due to Sterility Assurance Concerns

    Biom'up is recalling 1,682 units of Renovix Guided Healing Collagen Membranes due to a lack of sterility assurance. The products were distributed to a sole distributor in North Carolina.

    Product
    RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1107-2017·2017-02-08

    PerkinElmer Genetic Screening Processor Recalled for Corroding Axles

    PerkinElmer is recalling 24 Genetic Screening Processor instruments because defective ball bushing axles may corrode in humid conditions, risking contamination of sample wells.

    Product
    Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1122-2017·2017-02-08

    Mevion S250 Proton Therapy Units Recalled for Data Loss Error

    Mevion Medical Systems is recalling two S250 Proton Radiation Therapy units because a software error can cause Delta corrections to be lost.

    Product
    MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall affects 180 units distributed worldwide.

    Product
    Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1127-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled Due to Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers 155 units distributed worldwide.

    Product
    Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1124-2017·2017-02-08

    Synthes Radial Head Prosthesis Recalled for Potential Stem Loosening

    Synthes (USA) Products LLC is recalling 50,311 units of the Radial Head Prosthesis System because the radial stem may loosen post-operatively at the stem bone interface.

    Product
    Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1135-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising product sterility.

    Product
    Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1111-2017·2017-02-08

    Organ Preservation Solution Recalled for Potential Bacterial Contamination

    Organ Recovery Systems is recalling SPS-1 Static Preservation Solution bags due to potential bacterial contamination.

    Product
    SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1121-2017·2017-02-08

    Medtronic Strata II Valves Recalled for Pressure Discrepancies

    Medtronic is recalling Strata II and Strata NSC valves used for hydrocephalus management due to reported discrepancies between the set pressure level and x-ray readings.

    Product
    Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve is a shunt component designed to allow for continuous flow of cerebrospinal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1120-2017·2017-02-08

    Siemens IMMULITE PSA Kit Recall Due to Negative Bias Results

    Siemens is recalling two lots of IMMULITE PSA kits because they produce negative bias results, potentially affecting prostate cancer screening accuracy.

    Product
    IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1125-2017·2017-02-08

    Covidien Nellcor SpO2 Forehead Sensor Recalled for Latex Labeling Error

    FDA is recalling 7,453 units of the Covidien Nellcor SpO2 Forehead Sensor because the label incorrectly states the product is latex-free, while the headband contains latex.

    Product
    Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor¿ Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 40 kg.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1129-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling 252 Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The devices are used for breast tissue removal.

    Product
    Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1036-2017·2017-02-08

    Olympus Vanta XRF Analyzers Recalled for LED Warning Light Failure

    Olympus is recalling Vanta VCR and VMR XRF analyzers because the LED warning lights may fail to illuminate during X-ray emission.

    Product
    Olympus Scientific Solutions Americas Corporation (OSSA) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-1134-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling 326 Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers units distributed in the US and several international countries.

    Product
    Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1119-2017·2017-02-08

    Siemens Recalls IMMULITE PSA Kits Due to Negative Bias

    Siemens Healthcare Diagnostics is recalling IMMULITE PSA kits worldwide because patient samples show an average negative bias of approximately -22%.

    Product
    IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1112-2017·2017-02-08

    Implant Direct Recalls SwishTapered Implants Due to Packaging Error

    Implant Direct Sybron Manufacturing is recalling 17 SwishTapered Implants because the packaged extender was in the incorrect position, which may cause micro-leakage and infection.

    Product
    SwishTapered Implant
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1130-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling 185 units of Intact Disposable Wands because the sterile barrier was breached, compromising sterility.

    Product
    Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1131-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers 320 units distributed worldwide.

    Product
    Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0923-2017·2017-02-01

    Philips Allura Xper FD10 X-ray System Recalled for Loose Screws

    Philips is recalling one Allura Xper FD10 X-ray system because production errors left screws loose, potentially causing the C-arm to rotate uncontrolled.

    Product
    Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1065-2017·2017-02-01

    Villa Radiology Systems Recalls Apollo DRF X-Ray Systems Due to Injury Risk

    Villa Radiology Systems LLC is recalling 66 Apollo DRF multi-function x-ray systems because a chain of faults led to an injury involving inadvertent movement activation.

    Product
    Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-1063-2017·2017-02-01

    Villa Radiology Juno DRF X-ray Systems Recalled for Injury Risk

    Villa Radiology Systems LLC is recalling Juno DRF x-ray systems after an injury occurred due to a chain of faults involving physical barriers and labeling.

    Product
    Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-0925-2017·2017-02-01

    Philips Allura Xper FD20/15 C-arm Recall Due to Loose Screws

    Philips is recalling two Allura Xper FD20/15 systems because production errors may cause C-arm screws to loosen, leading to uncontrolled rotation.

    Product
    Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1064-2017·2017-02-01

    Villa Radiology Systems Recalls Apollo X-Ray Systems Due to Injury Risk

    Villa Radiology Systems LLC is recalling 66 Apollo multi-function x-ray systems after an injury incident involving inadvertent movement activation and delayed emergency stop response.

    Product
    Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-0924-2017·2017-02-01

    Philips Allura Xper FD20 C-arm Recall Due to Loose Screws

    Philips is recalling two Allura Xper FD20 C-arm systems because production errors left screws loose, posing a risk of uncontrolled rotation.

    Product
    Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology(EP).
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1099-2017·2017-02-01

    Roche Recalls Accu-Chek Connect App Due to Insulin Dosing Errors

    Roche Diabetes Care is recalling the Accu-Chek Connect app because software defects may cause incorrect insulin bolus recommendations, potentially leading to hypoglycemia.

    Product
    Accu-Chek Connect Diabetes Management App
    Category
    Medical Device
    Distribution
    Distributed nationwide