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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11901–11925 of 13748

  • HighFDA (Devices)·Z-0940-2022·2022-04-20

    CLARAVUE ECG Electrode May Fail to Deliver Effective Defibrillation

    CLARAVUE Pre-wired ECG electrodes may not meet electrical safety standards for defibrillation, potentially delivering an ineffective electrical charge during emergency use. This is a Class II recall affecting devices nationwide.

    Product
    CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0934-2022·2022-04-20

    Surgical Head Fixation Device Mount Clamp Assembly Deflection Recall

    Deerfield Imaging recalls the Trumpf Mount Clamp Assembly component used in surgical head fixation devices. The clamp may deflect during use and become difficult to loosen after procedures, potentially requiring surgical intervention.

    Product
    Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and #119630-000, which are used with ORT400 operating room tables.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0939-2022·2022-04-20

    Cardiac electrode fails electrical safety test; defibrillation may not work

    The CLARAVUE Pre-wired Electrode does not meet electrical safety standards for defibrillators. It may not deliver effective electrical charge during emergency defibrillation.

    Product
    CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0872-2022·2022-04-20

    Conductivity Sensors in Dialog Hemodialysis Systems May Crack and Leak

    B Braun Medical Inc is recalling conductivity sensors used in Dialog and Dialog+ hemodialysis systems due to potential cracks that could cause dialysate circuit leaks, affecting ultrafiltration during treatment.

    Product
    Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S (UDI 0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0873-2022·2022-04-20

    Hemodialysis Conductivity Sensors recalled for potential cracks and dialysate leaks

    B Braun Medical Inc is recalling conductivity sensors used in Dialog hemodialysis systems due to potential cracking during use, which could cause leaks in the dialysate circuit and improper ultrafiltration. Affected patients should contact their healthcare provider.

    Product
    Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number 3456103A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S (UDI 0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0936-2022·2022-04-20

    Recalled CLARAVUE Pre-wired Electrode Set May Fail During Defibrillation

    Graphic Controls is recalling CLARAVUE Pre-wired Electrode sets because they fail to meet electrical safety specifications for defibrillators, potentially delivering inadequate charge during emergency treatment.

    Product
    CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0922-2022·2022-04-20

    FDA Recalls Abbott Vascular Priority Pack Accessory Kits for Leak and Connection Issues

    Abbott Vascular is recalling 23 lots of Priority Pack accessory kits and packs due to reports of leaks and loose connections in the devices.

    Product
    20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-02 (2019-03-01)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0916-2022·2022-04-20

    ROTAWIRE guidewires recalled due to potentially compromised sterile pouch seals

    Boston Scientific is recalling ROTAWIRE Drive guidewires due to potentially open pouch seals that could compromise product sterility. Affected units were distributed in the US, territories, Japan, and Canada.

    Product
    ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0925-2022·2022-04-20

    Abbott Vascular Plus 30 Priority Pack Recalled for Connection Leaks

    Abbott Vascular is recalling seven lots of the Plus 30 Priority Pack due to increased reports of leaks and intermittent loose connections in the vascular devices.

    Product
    Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (2019-03-01)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0906-2022·2022-04-20

    Integra Universal Flexible Arm Recall: Internal Cable May Break

    Integra LifeSciences is recalling the Universal Flexible Arm (part number REF 1362275) because excess tightening force can break the internal cable at the tip, rendering the device unusable.

    Product
    Integra Universal Flexible Arm part number REF 1362275
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0911-2022·2022-04-20

    Nextra Hammertoe Correction System surgical instruments recalled for defective connector

    Nextremity Solutions recalls 459 units of the Nextra Hammertoe Correction System due to an oversized proximal driver end that prevents proper connection and removal during surgery.

    Product
    Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0937-2022·2022-04-20

    CLARAVUE Pre-wired Electrode fails to meet electrical safety specification

    Graphic Controls' CLARAVUE Pre-wired Electrode units fail to meet electrical safety specifications required for defibrillation. The device delivers an inefficient electrical charge and may result in ineffective defibrillation.

    Product
    CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0943-2022·2022-04-20

    Ventilator trolley mounting brackets can detach and cause device to fall

    The mounting brackets on Breas Ventilator Trolleys can become detached, allowing ventilators to fall. This poses an injury risk to people near the equipment.

    Product
    Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0913-2022·2022-04-20

    Hammertoe Correction Surgical System Recalled for Driver Connection Defect

    Nextremity Solutions recalls the Nextra Hammertoe Correction System because the driver's proximal end is oversized, making it difficult to connect and remove from the implant, potentially delaying surgery.

    Product
    Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0919-2022·2022-04-20

    MUSE Cardiology System edits and diagnosis data lost after test signed

    GE Healthcare's MUSE Cardiology Information System may lose test measurement edits and diagnosis statements after signing. The Class II recall affects 147 units in the US and internationally.

    Product
    MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0905-2022·2022-04-20

    Breast Milk Analyzer Lacks FDA Validation, Risks Sub-optimal Infant Nutrition

    Stanbio Laboratory's Creamatocrit Plus breast milk analyzer was marketed without required FDA 510(k) clearance. Its performance has not been validated, and erroneous results could lead to inadequate nutritional supplementation for infants.

    Product
    Separation Technology Creamatocrit Plus, Catalog Number: 100-146
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0929-2022·2022-04-20

    Siemens Atellica CH Hemoglobin A1c Reagent Kits Recalled for Quality Control Issues

    Siemens Healthcare is recalling Atellica CH Hemoglobin A1c reagent kits due to potential reagent carryover affecting quality control and patient test results. The issue may cause inaccurate diabetes monitoring measurements.

    Product
    Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0930-2022·2022-04-20

    Siemens Atellica CH Fructosamine Reagent Recalled for Potential Carryover

    Siemens Healthcare Diagnostics is recalling Atellica CH Fructosamine reagent (lots 211359, 211451) due to potential reagent carryover that could affect diagnostic test accuracy.

    Product
    Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0932-2022·2022-04-20

    Hydroxybutyrate Test Kits Recalled Due to Improper Storage

    Medline's Hydroxybutyrate LiquiColor Tests are recalled due to improper storage that may cause delayed test results. The recall affects 45 units distributed across 16 U.S. states.

    Product
    Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0917-2022·2022-04-20

    FDA Recalls Touch Screen Modules for IVUS Imaging Systems

    Volcano Corp is recalling MM-TSM touch screen modules used with IntraSight Integrated IVUS systems because they may crack or become damaged, potentially rendering the imaging equipment non-functional.

    Product
    MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-0933-2022·2022-04-20

    Medical Device Linearity Standards Recalled Due to Improper Storage Controls

    Medline Industries is recalling Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards due to improper storage controls that may affect test result timing. The recall affects 10 boxes distributed to healthcare facilities in six states.

    Product
    Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604, IVD.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0926-2022·2022-04-20

    Philips Autoclavable Temperature Probes: Updated Cleaning Instructions

    Philips is updating instructions for cleaning and disinfecting reusable autoclavable temperature probes due to revisions needed in the disinfection process.

    Product
    The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A, 21076A, 21078A, 989803162621, 989803162631, 989803162641.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0901-2022·2022-04-20

    IntraSight Mobile IVUS touch screen modules missing required labeling information

    IntraSight Mobile IVUS Systems touch screen modules lack required labeling information including device identifier and manufacturer information. Affected units were distributed to healthcare facilities in the US and internationally.

    Product
    IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0883-2022·2022-04-13

    Abbott Alinity m HBV Device Misquantitation of Negative Samples

    Abbott Molecular recalled Alinity m HBV Application Specification Files due to potential for incorrect high quantitation results on negative samples, which could affect test accuracy for hepatitis B virus detection.

    Product
    Alinity m HBV Application Specification File (US and CE)
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0893-2022·2022-04-13

    SPECT/CT Imaging Systems Recalled Due to Defective Balancing Weight Bolts

    Siemens is recalling seven Symbia Intevo SPECT/CT imaging systems due to a quality defect in the bolts that secure the CT balancing weights, which could create a safety issue.

    Product
    Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
    Category
    Medical Device
    Distribution
    0 states