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 deaths or serious injuries are reported, 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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12301–12325 of 13802

  • HighFDA (Devices)·Z-0590-2022·2022-02-16

    GE Healthcare MRI Systems Cryogen Ventilation System Defect Recall

    GE Healthcare is recalling SIGNA Premier MRI systems due to a cryogen ventilation system that does not meet venting requirements. Approximately 17,228 affected devices were distributed worldwide.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0575-2022·2022-02-16

    Baxter MiniCap PD Transfer Set Recall—Damage from Cleaning Products

    Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets worldwide because cleaning products containing hydrogen peroxide, bleach, alcohol, or solvents may cause the devices to leak or crack.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0630-2022·2022-02-16

    BD Veritor Plus Analyzer may overheat when using unauthorized power adapter

    BD Veritor Plus Analyzer devices may overheat or catch fire if powered with an unauthorized AC adapter instead of the manufacturer-provided one. The recall affects approximately 129,848 analyzers distributed worldwide.

    Product
    BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0562-2022·2022-02-16

    Novalung Sensor Box Communication Failure May Disable Flow Measurement

    The Novalung Sensor Box may experience communication failures between its flow sensor and sensor box component, potentially disabling flow measurement and air bubble detection. The recall affects 115 units distributed across 16 US states.

    Product
    Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0582-2022·2022-02-16

    Medical device reference standard contaminated with bacterial species

    Microbiologics recalls KWIK-STIK Streptococcus pneumoniae reference standards due to potential contamination with Staphylococcus epidermidis, E. coli, and Staphylococcus warneri affecting 271 units worldwide.

    Product
    KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-STIK(TM) 6 Pack. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0621-2022·2022-02-16

    GE Healthcare MRI Superconducting Magnet Cryogen Ventilation System Defect

    GE Healthcare is recalling 17,228 MRI superconducting magnets due to a potential cryogen ventilation system defect. The systems may not meet required venting specifications.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0567-2022·2022-02-16

    Dunnage Case Shipped Instead of THERAKOS CELLEX Photopheresis Kits

    A dunnage case containing sterilization packaging was shipped in place of THERAKOS CELLEX Photopheresis Procedural Kits. The material is not intended for customer use and should not be used.

    Product
    THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0637-2022·2022-02-16

    LYSO Disk microorganism culture device mislabeled with incorrect strain

    Microbiologics' LYSO Disk culture disks labeled as containing Actinomyces odontolyticus have been found to actually contain Eggerthella lenta. The mislabeling affects products distributed to Canada and Germany.

    Product
    LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0636-2022·2022-02-16

    Microbiologics Recalls KWIK-STIK Microorganism Reference Material Due to Organism Mislabeling

    Microbiologics Inc is recalling KWIK-STIK microorganism reference kits labeled as Actinomyces odontolyticus but containing Eggerthella lenta. The mislabeling could cause incorrect organism identification in laboratory testing.

    Product
    KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccan
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0581-2022·2022-02-16

    Medical device lot number misprinted on packaging

    Microbiologics Inc recalls KWIK-STIK 2 Pack Clostridium perfringens reference material (lot 318-234-4) because the foil pouch shows incorrect lot number 218-234-4. The correct number is on the device label.

    Product
    KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0480-2022·2022-02-09

    COVID-19 Rapid Antigen Test Kit Distributed Without FDA Approval

    CovClear COVID-19 Rapid Antigen Test kits (284,575 units) were distributed nationwide without FDA marketing approval, clearance, or authorization. All lots are recalled.

    Product
    CovClear COVID-19 Rapid Antigen Test, ATG 900-031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0481-2022·2022-02-09

    COVID-19 Test Kits Recalled for Unauthorized FDA Marketing and Sale

    Empowered Diagnostics LLC recalled COVID-19 test kits (ImmunoPass, NAB 900-60) sold nationwide without FDA approval. Approximately 2,100 units were distributed without required marketing clearance or authorization.

    Product
    ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0529-2022·2022-02-09

    Baxter Spectrum IQ Infusion Pumps Recalled Due to Potential Medication Delivery Failure

    Baxter Healthcare is recalling 241,304 Spectrum IQ infusion pumps due to potential medication delivery failure without user alert. The issue may occur during administration set setup or when occlusion alarms are not fully resolved.

    Product
    Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0550-2022·2022-02-09

    OXY-1 System Console Experiences Power Interruption During Use

    OXY-1 System consoles used during cardiac support procedures may experience power interruptions that disrupt patient therapy, potentially causing prolonged oxygen deprivation.

    Product
    OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is sold separately and is not part of this recall.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0530-2022·2022-02-09

    Baxter SIGMA Spectrum infusion pumps recalled for medication delivery failures

    Baxter is recalling 146,502 SIGMA Spectrum infusion pumps due to potential medication delivery failures that may occur without alerting clinicians. The issue is linked to administration set setup and occlusion alarm resolution.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0535-2022·2022-02-09

    DIXI Medical Microdeep Depth Electrode Sterile Barrier Compromise Recall

    DIXI MEDICAL USA is recalling Microdeep Depth Electrodes used in neurological monitoring and stimulation due to potential deformation of the internal sterile packaging. The compromised sterile barrier could allow contamination before use.

    Product
    The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length va
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0549-2022·2022-02-09

    Philips eCareManager versions recalled due to unapproved Sentry Score software

    Philips is recalling certain versions of eCareManager software because the Sentry Score feature was not approved by FDA prior to distribution. Users should contact Philips for updated information.

    Product
    eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for use by trained medical staff providing supplemental remote support to bedside care
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0545-2022·2022-02-09

    Cryptococcal Antigen Test Kits Recalled for Reduced Detection Specificity

    Immuno-Mycologics recalls 411 Cryptococcal Antigen test kits (lots F1021035, F1021036) for reduced specificity (90% vs. 99%), which may cause false-positive results leading to unnecessary anti-fungal therapy.

    Product
    CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0534-2022·2022-02-09

    Microdeep Depth Brain Electrodes recall due to sterile barrier compromise risk

    DIXI Medical is recalling 484 Microdeep Depth Electrodes nationwide due to potential deformation of internal packaging that could compromise the sterile barrier of these brain recording devices.

    Product
    The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length va
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0556-2022·2022-02-09

    Pelvic floor repair device may lack required packaging component

    FEMSelect Ltd is recalling 141 units of the EnPlace trans-vaginal pelvic floor repair system because certain lots may not have been packaged with the required Channel Tube Limiter accessory.

    Product
    The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity. The anchors are pre-loaded inside the device shaft and are ready for use. A thimble is also supplied, as an accessory for the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2022·2022-02-09

    Spinal Fusion Implant Insert Recalled for Assembly Defect

    XTANT Medical is recalling 24 units of the X060-0270 8mm Titanium Insert for the Axle Interspinous Fusion System due to a manufacturing defect that prevents proper assembly of crossbar plates. The defect could affect the device's function during spinal fusion procedures.

    Product
    X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0540-2022·2022-02-09

    DIXI Microdeep Depth Electrode sterile barrier packaging defect

    DIXI Medical Microdeep Depth Electrodes are recalled due to potential deformation of the blister pack packaging that could compromise the sterile barrier. 345 units nationwide are affected.

    Product
    The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length va
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0542-2022·2022-02-09

    DIXI Medical Microdeep Depth Electrode packaging defect may compromise sterility

    DIXI MEDICAL USA is recalling Microdeep Depth Electrodes due to potential deformation of the internal packaging (blister pack) that could compromise the sterile barrier. The recall affects 365 units distributed nationwide.

    Product
    The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length va
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0555-2022·2022-02-09

    Young Dental Sterilization Indicator Labels May Contain Wrong Type

    YOUNG DH Dry Heat Indicator Labels used in healthcare sterilization may contain TTS Indicator Labels instead. Healthcare providers should verify package contents before use to ensure proper sterilization monitoring.

    Product
    YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0553-2022·2022-02-09

    ARIES HSV 1&2 Diagnostic Cassettes May Leak, Affecting Test Results

    Luminex Corporation is recalling ARIES HSV 1&2 Assay cassettes (lot numbers AB3600A and AB3560A) due to a confirmed 0.9% leak rate. Leaking cassettes may cause incorrect or delayed test results.

    Product
    ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
    Category
    Medical Device
    Distribution
    Distributed nationwide